Company · US
Arrow International Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2025. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
708recalls (47 in 12 months)
609recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 156 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 89 |
| CAZ | Anesthesia Conduction Kit | 76 |
| DSP | System, Balloon, Intra-Aortic And Control | 70 |
| MSD | Catheter, Hemodialysis, Implanted | 54 |
| DQY | Catheter, Percutaneous | 41 |
| DYB | Introducer, Catheter | 37 |
| DQX | Wire, Guide, Catheter | 32 |
| FPA | Set, Administration, Intravascular | 21 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 19 |
| BSO | Catheter, Conduction, Anesthetic | 18 |
| MEB | Pump, Infusion, Elastomeric | 17 |
| DXE | Catheter, Embolectomy | 10 |
| KDD | Kit, Surgical Instrument, Disposable | 6 |
| OBJ | Catheter, Ultrasound, Intravascular | 6 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 5 |
| KGZ | Accessories, Catheter | 4 |
| KKX | Drape, Surgical, Antimicrobial | 4 |
| KZH | Introducer, Syringe Needle | 4 |
| LDF | Electrode, Pacemaker, Temporary | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2025 | K250542 | AC3 Range Intra-Aortic Balloon Pump Arrow International, LLC | DSP |
| Aug 30, 2023 | K232343 | AC3 Series IABP Arrow International, LLC | DSP |
| Feb 13, 2023 | K222341 | Arrow 0.2 Micron Flat Filter, GVS Arrow International, LLC | CAZ |
| May 27, 2020 | K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Arrow International, Inc. | DSP |
| Apr 9, 2020 | K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Arrow International, Inc. | DSP |
| Jun 28, 2019 | K190101 | UltraFlex IAB Arrow International, Inc. | DSP |
| Jun 13, 2019 | K190117 | Fiberoptix IAB Arrow International, Inc. | DSP |
| Mar 31, 2017 | K162820 | AC3 Series IABP System Arrow International, Inc. | DSP |
| Jul 7, 2014 | K141051 | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU Arrow International, Inc. | MSD |
| May 10, 2013 | K130192 | NEXTSTEP RETROGRADE Arrow International, Inc. | MSD |
| Apr 26, 2013 | K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc. | LJS |
| Dec 21, 2012 | K122690 | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE Arrow International, Inc. | CAZ |
| Aug 28, 2012 | K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER Arrow International, Inc. | CAZ |
| Jun 21, 2012 | K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS Arrow International, Inc. | LJS |
| Jun 27, 2008 | K080604 | PRESSURE INJFECTABLE PICC Arrow International, Inc. | LJS |
| Jan 15, 2008 | K073451 | PRESSURE INJECTABLE PICC Arrow International, Inc. | LJS |
| Aug 30, 2007 | K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow International, Inc. | FOZ |
| Aug 24, 2006 | K061289 | ARROW PRESSURE INJECTABLE PICC Arrow International, Inc. | LJS |
| Oct 15, 2004 | K041740 | SILICONE COATED GUIDEWIRE Arrow International, Inc. | DQX |
| May 14, 2004 | K040666 | STEP-TIP CHRONIC HEMODIALYSIS CATHETER Arrow International, Inc. | MSD |
| Feb 13, 2004 | K040078 | CANNON II PLUS Arrow International, Inc. | MSD |
| Apr 23, 2003 | K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK Arrow International, Inc. | CAZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A;
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018 Open, Classified |
DQX | K160018 K810675 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
CVC KIT: 16 GA X 8IN/AK-04210,
CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300,
CVC KIT: 14 GA X 6 IN/CK-04711 Open, Classified |
FMF | K781978 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PICC ACCESS TRAY/ASK-04001-CG1 Open, Classified |
LJT | K003006 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A;
AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A;
AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A;
AGBA PI MIDLINE 1L: 4.5FR X 15 Open, Classified |
OWL | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PSI KIT: 7 FR X 4 IN/ASK-09701-UP;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5;
PSI KIT: 8.5 FR/ASK-09807-UC;
PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2;
PSI KIT: 9 FR X 10 C Open, Classified |
OFL | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/ASK-04001-MC3 Open, Classified |
PXB | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC;
RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW;
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5;
CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH;
CAT Open, Classified |
OFK | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B;
SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C;
SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B Open, Classified |
OFK | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
SPINAL ANESTHESIA KIT/ASA-24090-SB;
SPINAL ANESTHESIA KIT/ASA-24103-SB;
SPINAL ANESTHESIA KIT/ASA-25090-SB;
SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA;
SPINAL ANESTHESIA KIT: 25 Open, Classified |
BSP | K911202 K911260 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F,
AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1,
AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM,
AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1,
AH Open, Classified |
PPO | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC Open, Classified |
PND | K213855 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PARACENTESIS KIT/ASK-00376-JHH Open, Classified |
KDD | K874063 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/GU-04020;
PSI KIT: 8.5 FR/AK-09803-CDC;
PSI KIT: 9 FR/AK-09903-CDC;
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1;
PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
PSI KIT: 9 FR X 10 Open, Classified |
DYB | K002507 K011761 +2 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/ASK-04001-JHH;
ACCESS TRAY/ASK-04001-LMDTG;
PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1;
3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2;
MULTILUMEN PI CVC KIT: 3L 7 F Open, Classified |
LRS | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU Open, Classified |
LDF | K960479 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
DRAINAGE KIT/AK-01600,
DRAINAGE KIT/AK-01601,
DRAINAGE KIT/ASK-01601-MM,
THORACENTESIS KIT/AK-01000-T,
THORACENTESIS KIT/AK-01000,
THORACENTESIS KIT/ASK-01000-CHP,
DRAINAGE KIT/ASK-01 Open, Classified |
PAD | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F Open, Classified |
LFJ | K895417 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 Open, Classified |
GBW | K811627 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC;
PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC;
AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A;
AGBA PI JACC KIT: 2-L 5.5 FR X Open, Classified |
OBJ | K132133 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC;
AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB;
AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV;
AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DL Open, Classified |
LJS | K042126 K112896 +4 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6
RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP
ACCESS TRAY/ASK-04001-MS
RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1
VESSEL CATH KIT: 20GA X 5 Open, Classified |
DQY | K021120 K171146 +3 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH;
CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F;
CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F;
3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH;
3L PI CV Open, Classified |
LRS | K071538 K900263 +2 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2;
PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2 Open, Classified |
LRS | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC;
AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC;
AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A;
AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A;
AHDC KIT: Open, Classified |
NIE | K143102 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F;
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122;
HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC;
HEMODIALYSIS KIT 2L: 14 FR X 2 Open, Classified |
MPB | K984022 K993933 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A Open, Classified |
PPO | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1;
EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501;
EPIDURAL CATHETERIZATION KIT/AK-05502;
EPIDURAL CATHETERIZATION KIT/AK-05502D;
EPIDUR Open, Classified |
BSO | K140110 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS
AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS
AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV
PICC KIT: 2L 5.5 FR X 55 CM Open, Classified |
PWR | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4;
PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1;
PSI KIT: 9 FR X 4 1/8 IN (10 CM Open, Classified |
OFC | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1;
RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A;
ARTERIAL LINE KIT/AK-04510-S;
ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC;
ARTERIAL LINE Open, Classified |
OFB | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB;
AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC;
ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1;
ARROW(R) VPS(R) ACCESS KIT/ASK Open, Classified |
OEZ | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PACING PSI KIT: 6 FR/AI-06210-KS,
PACING PSI KIT: 5 FR 2-L/AI-07155-KS,
PACING PSI KIT: 5 FR 2L/ASK-07155-UPM Open, Classified |
OES | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU Open, Classified |
POZ | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/ASK-04001-SUH-S;
ACCESS TRAY/ASK-04001-VM1;
STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS;
STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
STIMUCATH SFTY KIT: Open, Classified |
CAZ | K001587 K103658 +4 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU Open, Classified |
PYC | None listed |
| May 13, 2026 | ARROW INTERNATIONAL, LLC NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX;
NextStep Antegrade Hemodialysi Open, Classified |
MSD | K111117 K111900 |
| May 13, 2026 | ARROW INTERNATIONAL, LLC Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP;
Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Open, Classified |
MSD | K111117 |
| May 13, 2026 | ARROW INTERNATIONAL, LLC Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, Open, Classified |
MSD | K141051 |
| May 13, 2026 | ARROW INTERNATIONAL, LLC Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I Open, Classified |
MSD | K111117 |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC Arrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC
UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671
The MAC Multi-Lumen Centr Open, Classified |
OFC | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2
UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670
The MAC Multi-Lumen Central Venous Access Open, Classified |
OFC | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1
UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011
The Arrowg+ard technology is intended to provide protect Open, Classified |
LRS | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL
VENOUS CATHETER
REF ASK-42802-PLH
UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140
REF ASK-45703-MGH
UDI code: ( Open, Classified |
FOZ | K071538 |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM
UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409
The Arrow Epidural Catheter Open, Classified |
BSO | K140110 |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
The Arrow percutaneous sheath introducer permits venous acce Open, Classified |
OFL | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC ARROW RADIAL ARTERY CATHETERIZATION KIT
REF ASK-04220-UCL1
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
REF ASK-04020-EUH2
UDI code: (01)10801902213379(17)270731(11)251218(10)33F25 Open, Classified |
OFB | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC Arrow Echogenic Introducer Needle REF ASK-04001-BWK2
UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
This device is intended for injection or aspiration of fluids. The needle protectio Open, Classified |
OWL | None listed |
| Sep 26, 2024 | ARROW INTERNATIONAL Inc. Arrow Arterial Kits and Trays as follows:
(1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;
(2) Arrow Arterial Access Tray with 0.021" Spring- Open, Classified |
DQX | K810675 K914531 |
| Jun 3, 2024 | ARROW INTERNATIONAL Inc. Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,
a) REF IAB-05830-U;
b) REF IAB-05840-U Open, Classified |
DSP | K000729 K993966 |
| Jun 3, 2024 | ARROW INTERNATIONAL Inc. Arrow UltraFlex Intra-Aortic Balloon Catheter Kit,
a) REF IAB-06830-U;
b) REF IAB-06840-U;
c) REF IAB-06850-U Open, Classified |
DSP | K000729 K190101 |
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