Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | K142829 |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | K142829 |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | K142829 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Cat Terminated |
DYB | K022634 |
| May 27, 2020 | Medtronic Vascular Galway DBA Medtronic Ireland Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. Terminated |
DYB | K181817 |
| May 21, 2020 | Baylis Medical Company Inc. NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK Terminated |
DYB | K102948 |
| May 21, 2020 | Baylis Medical Company Inc. TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, T Terminated |
DYB | K102948 |
| Apr 23, 2020 | Acutus Medical Inc Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly Terminated |
DYB | K170373 |
| Apr 23, 2020 | Acutus Medical Inc Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly Terminated |
DYB | K170373 |
| Apr 23, 2020 | Acutus Medical Inc Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly Terminated |
DYB | K170373 |
| Apr 23, 2020 | Acutus Medical Inc Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly Terminated |
DYB | K170373 |
| Dec 20, 2019 | Arrow International Inc Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters
ASK-09801-UPM Terminated |
DYB | K780532 |
| Dec 9, 2019 | Abbott Medical Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, cl Terminated |
DYB | K914090 |
| Dec 9, 2019 | Abbott Medical Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Terminated |
DYB | K954317 |
| Nov 18, 2019 | W. L. Gore & Associates Inc. Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ. Terminated |
DYB | K160254 |
| Sep 12, 2019 | Merit Medical Systems, Inc. Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein. Terminated |
DYB | K173750 |
| Aug 6, 2019 | Arrow International Inc Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit
Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central ci Terminated |
DYB | None listed |
| Aug 6, 2019 | Arrow International Inc 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters
Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue pe Terminated |
DYB | K011761 |
| May 28, 2019 | Terumo Medical Corporation Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19,
PRTSOLO-20 Terminated |
DYB | K152498 |
| May 28, 2019 | Terumo Medical Corporation SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925,
SR-1935,
SR-2025,
SR-2035,
SR-2225,
SR-2235,
SR-2425,
SR-2435 Terminated |
DYB | K152498 |
| May 28, 2019 | Terumo Medical Corporation SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425,
STFI-1435,
STFI-1625,
STFI-1635,
STFI-1825,
STFI-1835,
STFI-1925,
STFI-1935,
STFI-2125,
STFI-2135
Product Usage:
The Terminated |
DYB | K100819 |
| Dec 21, 2018 | Cook Inc. Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 Terminated |
DYB | None listed |
| May 23, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous ac Terminated |
DYB | K780532 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 Terminated |
DYB | K000313 |
| May 2, 2018 | Galt Medical Corporation Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10;
c) DIL-015-50;
d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-04 Terminated |
DYB | None listed |
| May 2, 2018 | Galt Medical Corporation Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055 Terminated |
DYB | K043525 K173287 |
| May 2, 2018 | Galt Medical Corporation 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12;
2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11;
3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) IN Terminated |
DYB | None listed |
| May 2, 2018 | Galt Medical Corporation 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36;
2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog Terminated |
DYB | K043525 K173287 |
| Apr 11, 2018 | Arrow International Inc 9 Fr. Radiopaque
Polyurethane Sheath/Dilator
with Integral Hemostasis Valve/Side Port
for use with 7 - 8 Fr. Catheters and
Arrow Percutaneous Introducer System; Product codes: SS-09903-S Terminated |
DYB | K780532 |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1 Terminated |
DYB | K780532 |
| Apr 11, 2018 | Arrow International Inc Sheath Adapter with Cath-Gard Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847 Terminated |
DYB | K021723 |
| Apr 11, 2018 | Arrow International Inc ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: MSO-45703-AHS Terminated |
DYB | K940079 |
| Apr 11, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath
and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS Terminated |
DYB | K940079 |
| Apr 11, 2018 | Arrow International Inc Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018 Terminated |
DYB | K780532 |
| Apr 11, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Prod Terminated |
DYB | K940079 |
| Apr 11, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB Terminated |
DYB | K780532 |
| Apr 11, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA Terminated |
DYB | K780532 |
| Apr 11, 2018 | Arrow International Inc Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters
; Product Codes: ASK-09903-UM Terminated |
DYB | K940079 |
| Mar 5, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters.
Permit Terminated |
DYB | K940079 |
| Mar 5, 2018 | Arrow International Inc Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr.
Catheters.
Permits venous access and cathe Terminated |
DYB | K780532 |
| Dec 29, 2017 | Sterilmed Inc St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single u Terminated |
DYB | K152090 |
| Dec 22, 2017 | Arrow International Inc Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD Terminated |
DYB | K940079 |
| Dec 22, 2017 | Arrow International Inc (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with
7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1 Terminated |
DYB | K780532 |
| Dec 14, 2017 | Merit Medical Systems, Inc. PreludeSNAP Splittable Hydrophilic and
non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS Terminated |
DYB | K143255 K152381 |
| Dec 14, 2017 | Kalila Medical Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medi Terminated |
DYB | K162427 |
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