Company ยท US
Arrow Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2010. Name variants (Inc, Corp, punctuation) are merged.
110510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 15 |
| CAZ | Anesthesia Conduction Kit | 11 |
| DQY | Catheter, Percutaneous | 11 |
| DYB | Introducer, Catheter | 9 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 8 |
| DQX | Wire, Guide, Catheter | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 4 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| JOL | Catheter And Tip, Suction | 2 |
| KGZ | Accessories, Catheter | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 2 |
| DPN | Thin Layer Chromatography, Propoxyphene | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| DRC | Trocar | 1 |
| DXE | Catheter, Embolectomy | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2010 | K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 Arrow Intl., Inc. | LJS |
| Dec 18, 2009 | K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 Arrow Intl., Inc. | DQY |
| Oct 10, 2007 | K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES Arrow Intl., Inc. | KKX |
| Sep 26, 2007 | K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT Arrow Intl., Inc. | FMI |
| Jul 17, 2007 | K071111 | NON-ABSORBABLE SILK SUTURE Arrow Intl., Inc. | GAP |
| Apr 6, 2006 | K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES Arrow Intl., Inc. | DSP |
| Aug 27, 2004 | K042126 | PICC Arrow Intl., Inc. | LJS |
| Jul 12, 2004 | K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP Arrow Intl., Inc. | FMI |
| May 6, 2004 | K040801 | INTRA-AORTIC BALLOON (IAB) Arrow Intl., Inc. | DSP |
| Apr 28, 2004 | K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR Arrow Intl., Inc. | DPN |
| Mar 1, 2004 | K040100 | ARROW ECHOGENIC INTRODUCER NEEDLE Arrow Intl., Inc. | DQX |
| Nov 25, 2003 | K031153 | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 Arrow Intl., Inc. | DPW |
| Oct 29, 2003 | K032962 | AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE Arrow Intl., Inc. | FOZ |
| May 9, 2003 | K022662 | DIATEK CANNON-CATHETER, MODEL CC5500 Arrow Intl., Inc. | MSD |
| Aug 8, 2002 | K021723 | SHEATH ADAPTER, MODEL SA-09847 Arrow Intl., Inc. | DYB |
| Jun 19, 2002 | K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 Arrow Intl., Inc. | CAZ |
| Jun 6, 2002 | K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 Arrow Intl., Inc. | DSP |
| May 2, 2002 | K021120 | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP Arrow Intl., Inc. | DQY |
| Oct 31, 2001 | K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc. | DYB |
| Oct 24, 2001 | K011056 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD Arrow Intl., Inc. | QEW |
| May 3, 2001 | K002256 | ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP Arrow Intl., Inc. | DSP |
| Mar 21, 2001 | K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc. | DYB |
| Mar 2, 2001 | K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U Arrow Intl., Inc. | DSP |
| Oct 27, 2000 | K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION Arrow Intl., Inc. | LJT |
| Sep 14, 2000 | K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO Arrow Intl., Inc. | MPB |
| Jul 12, 2000 | K001587 | 19 GA PLASTIC REINFORCED EPIDURAL CATHETER Arrow Intl., Inc. | CAZ |
| May 19, 2000 | K000729 | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL Arrow Intl., Inc. | DSP |
| Mar 8, 2000 | K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc. | FOZ |
| Feb 18, 2000 | K993966 | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER Arrow Intl., Inc. | DSP |
| May 26, 1999 | K991431 | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT Arrow Intl., Inc. | MPB |
| May 18, 1999 | K984022 | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT Arrow Intl., Inc. | MPB |
| May 4, 1999 | K990829 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 Arrow Intl., Inc. | MCW |
| Aug 31, 1998 | K982141 | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 Arrow Intl., Inc. | DXE |
| Aug 12, 1998 | K981782 | LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM Arrow Intl., Inc. | DYB |
| Jun 4, 1998 | K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U Arrow Intl., Inc. | DSP |
| Feb 13, 1998 | K970229 | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET Arrow Intl., Inc. | DYB |
| Jan 23, 1998 | K965209 | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) Arrow Intl., Inc. | DSP |
| Oct 17, 1997 | K970864 | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS Arrow Intl., Inc. | FOZ |
| Sep 16, 1997 | K963865 | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S Arrow Intl., Inc. | DSP |
| Aug 21, 1997 | K962577 | ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc. | FOZ |
| Jul 25, 1997 | K970080 | ARROW-TREROTOLA PTD CATHETER Arrow Intl., Inc. | MCW |
| Jun 17, 1997 | K963920 | 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, Arrow Intl., Inc. | DSP |
| Mar 4, 1997 | K963257 | PERIPHERALLY INSERTED MEDLINE CATHETER Arrow Intl., Inc. | LJS |
| Feb 4, 1997 | K963104 | 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM Arrow Intl., Inc. | DSP |
| Oct 24, 1996 | K963684 | A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) Arrow Intl., Inc. | LJT |
| Oct 17, 1996 | K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER Arrow Intl., Inc. | LDF |
| Jul 19, 1996 | K961652 | LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 Arrow Intl., Inc. | LJT |
| Jul 19, 1996 | K961615 | LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 Arrow Intl., Inc. | LJT |
| Jul 18, 1996 | K961583 | A PORT DETACHED CATHETER SYSTEM CATALOG #1002 Arrow Intl., Inc. | LJT |
| Jul 2, 1996 | K961358 | ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER Arrow Intl., Inc. | DSP |
Newest 50 of 110.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||