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) |
|---|---|---|---|
| Oct 5, 2016 | Oscor, Inc. OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM
D66CM Catalog # AB10218
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM
D84CM Catalog # AB101219
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM
D66CM Catalog # AB101218
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C120 S79CM
D84CM Catalog # AB101078
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C90 S79CM D84CM Catalog # AB101078
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C70 S79CM
D84CM Catalog # AB101077
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C55 S79CM
D84CM Catalog # AB101076
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C120 S61CM
D66CM Catalog # AB101075
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C70 S61CM
D66CM Catalog # AB101073
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C55 S61CM
D66CM Catalog # AB101072
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM
D84CM Catalog # AB081211
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM
D66CM Catalog # AB081210
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C120 S79CM
D84CM Catalog # AB081047
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C90 S79CM D84CM Catalog # AB081046
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctur Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C120 S61CM
D66CM Catalog # AB081043
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C90 S61CM D66CM Catalog # AB081042
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C70 S61CM D66CM Catalog # AB081041
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103
Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a sm Terminated |
DYB | K051655 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stif Terminated |
DYB | K051655 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffen Terminated |
DYB | K051655 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Terminated |
DYB | K051655 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened M Terminated |
DYB | K051655 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened M Terminated |
DYB | K051655 |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Terminated |
DYB | K051655 |
| Sep 6, 2016 | Terumo Medical Corporation PINNACLE Introducer Sheath
PINNACLE PRECISION ACCESS SYSTEM Sheath
PINNACLE TIF TIP" Introducer Sheath
PINNACLE R/O II Radiopaque Marker Introducer Sheath Terminated |
DYB | K111606 |
| Aug 22, 2016 | Cook Inc. Haskal Transjugular Intrahepatic Portal Access Set
Introducer, catheter
Intended for transjugular liver access in diagnostic and interventional procedures. Terminated |
DYB | None listed |
| Jun 7, 2016 | Medical Components, Inc dba MedComp Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490
Product Usage:
The 2F and 3F Vascu-Sheath Tea Terminated |
DYB | K130687 |
| Jan 20, 2016 | Cook Inc. Flexor Check-Flo Introducer, Catheter introducer,
Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC
Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional Terminated |
DYB | None listed |
| Jan 12, 2016 | Arrow International Inc Super Arrow-Flex Percutaneous Sheath Introducer Sets
REF CL-07035 or CL-07635 or CL-07735 or CL-07835
Super Arrow-Flex
Percutaneous Sheath Introducer Set
with Integral Hemostasis Valve/Side Port
and Terminated |
DYB | K924607 |
| Dec 18, 2015 | Boston Scientific Corporation Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide:
Product Description Material Number (UPN)
Guiding Sheath 5F, 45 cm, ST, CC H74939277545110
Guiding Sheath 5F, 45 cm, Terminated |
DYB | K150186 |
| Dec 14, 2015 | Stryker Instruments Div. of Stryker Corporation Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle)
20 units per case
The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall Terminated |
DYB | K812973 |
| Jul 18, 2015 | Cook Inc. Flexor RTPS Guiding Sheath
Product Usage:
The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional device Terminated |
DYB | None listed |
| Mar 17, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065.
The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of t Terminated |
DYB | K142684 |
| Oct 22, 2014 | St Jude Medical St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO.
The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), She Terminated |
DYB | K954317 |
| Sep 4, 2014 | Galt Medical Corporation GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO
Product Usage:
Used in percutaneous procedures to introduce catheters and other intravasc Terminated |
DYB | K112398 |
| Sep 4, 2014 | Galt Medical Corporation GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO
Product Usage:
Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral Terminated |
DYB | K112398 |
| Jun 4, 2014 | Arrow International Inc Arrow Percutaneous Sheath Introducer Kits
The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation. Terminated |
DYB | K780532 |
| May 13, 2014 | Greatbatch Medical Coaxial Micro-Introducer Kit.
Greatbatch Part Number/Bard Access Systems Order Number/Part Description
10636-001
8004011
Kit Coax 10 Pack 4FR Bard
10636-002
8005011
Kit Coax 10 Pack 5FR Bard
1063 Terminated |
DYB | K990705 |
| Mar 27, 2014 | Biocardia, Inc. Morph AccessPro Steerable Introducer;
6F Introducer, 90 cm working length:
Single use only.
BioCardia, Inc.
San Carlos, CA 94070
BioCardia Morph AccessPro is intended to provide a pathway through me Terminated |
DYB | K090999 |
| Mar 27, 2014 | Biocardia, Inc. Morph AccessPro Steerable Introducer;
6F Introducer, 45 cm working length
Single use only.
BioCardia, Inc.
San Carlos, CA 94070
BioCardia Morph AccessPro is intended to provide a pathway through medi Terminated |
DYB | K090999 |
| Feb 19, 2014 | Biocardia, Inc. MORPH ACCESSPRO Steerable Introducer;
6F introducer, 90 cm working length:
Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic:
BioCardia Inc.
San Carlos, CA 94070
Intended to Terminated |
DYB | K090999 |
| Dec 21, 2013 | B. Braun Medical, Inc. B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02.
Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or a Terminated |
DYB | K021094 |
| Dec 9, 2013 | Arrow International Inc Arrow Transradial Artery Access products
Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. Terminated |
DYB | K112554 K780532 |
| Nov 1, 2013 | Baylis Medical Corp * Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile.
Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three com Terminated |
DYB | K102948 |
| Sep 23, 2013 | Smiths Medical ASD, Inc. Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only
PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to p Terminated |
DYB | K871132 |
| Sep 18, 2013 | Access Scientific Inc POWERWAND Safety Introducer with Extended Dwell Catheter;
Catalog no. 92006.
Used to gain access to the vascular system to sample blood and administer fluids intravenously. Terminated |
DYB | K111417 K121748 +1 |
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