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) |
|---|---|---|---|
| Jun 10, 2009 | Merit Medical Systems, Inc. 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-6F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-6F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840 Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-5F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facili Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-5F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-5F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840 Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facilitate the percutaneous Terminated |
DYB | K082063 |
| Jun 10, 2009 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facilitate the percutaneous intr Terminated |
DYB | K082063 |
| Apr 9, 2009 | Boston Scientific Corp Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers:
M00456600,
M00456610,
M00456620,
M00456630,
M00456650,
M00456700,
M00456710 and
M00456760.
Manufactured by Thomas Medical Terminated |
DYB | K013866 K022067 +2 |
| Apr 9, 2009 | Boston Scientific Corp Convoy Advanced Delivery Sheath Kit, Model Numbers:
M0045660ST0,
M0045661ST0,
M0045662ST0,
M0045663ST0,
M0045665ST0,
M0045667ST0,
M0045670ST0,
M0045672ST0,
M0045675ST0,
M0045676ST0,
M0045690ST0,
M00 Terminated |
DYB | K013866 |
| Dec 2, 2008 | Medtronic, Inc. Medtronic Input TS 7F 11 cm
Ref: 071102A
Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a ve Terminated |
DYB | K955785 |
| Dec 2, 2008 | Medtronic, Inc. 7 F BardSelect 11cm Percutaneous Catheter Introducer Set
Ref: 070A11
Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a cathete Terminated |
DYB | K955785 |
| Dec 2, 2008 | Medtronic, Inc. 6 F BardSelect 11cm Percutaneous Catheter Introducer Set
Ref: 060A11
Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a cathete Terminated |
DYB | K955785 |
| Dec 2, 2008 | Medtronic, Inc. 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set
Ref: 050A11
Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a cathete Terminated |
DYB | K955785 |
| Nov 7, 2008 | C. R.Bard, Inc./BardElectrophysiology Division 7F Bard SSV 13 cm Split Sheath with Valve and sideport
Catalog Number: 808700
Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and cath Terminated |
DYB | K934901 |
| Nov 3, 2008 | Thomas Medical Products Inc 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS). Terminated |
DYB | K003731 K934901 |
| Oct 29, 2008 | Oscor, Inc. Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body. Terminated |
DYB | K073100 |
| Apr 16, 2008 | Cook, Inc. Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in the Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., ste Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Cook TPN Single Lumen Catheter set; Catheter introducer, includes 6.5 FRENCH, 90 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 18 Gage., 7 cm long Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 FRENCH, 65 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 19UT Gage., 7 cm lo Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-38. Cook Inc., Bloomington, IN 47404 Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35. Cook Inc., Bloomington, IN 47404 Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PL Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., steril Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0 cm long. Accepts devices up to 7.0 Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491. William Cook Europe A/S, Cook Inc., Bloomington, IN 47404. Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, st Terminated |
DYB | None listed |
| Apr 16, 2008 | Cook, Inc. Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,steri Terminated |
DYB | None listed |
| Dec 7, 2007 | Boston Scientific Corp Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientif Terminated |
DYB | K952828 |
| Mar 8, 2007 | Abbott Vascular, Inc. StarClose Vascular Closure System (Clip Applier & Exchange System),
Catalog Number: 14677;
Product is manufactured by:
Abbott Vascular Inc.,
400 Saginaw Drive,
Redwood City, CA 94063 Terminated |
DYB | K060902 |
| Mar 1, 2007 | St. Jude Medical / Daig Division FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. Terminated |
DYB | K964518 |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P Terminated |
DYB | K001139 |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A Terminated |
DYB | K001139 |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M Terminated |
DYB | K001139 |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M Terminated |
DYB | K001139 |
| Feb 28, 2007 | Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS Terminated |
DYB | K001139 |
| Jun 24, 2006 | B. Braun Medical, Inc. B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton. Terminated |
DYB | None listed |
| Jun 3, 2006 | St. Jude Medical / Daig Division St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agil Terminated |
DYB | K042623 |
| Jan 6, 2006 | Oscor Inc. Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant) Terminated |
DYB | K871153 |
| Jan 6, 2006 | B. Braun Medical, Inc. 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton. Terminated |
DYB | None listed |
| Dec 17, 2005 | Thomas Medical Products Inc Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case. Terminated |
DYB | K934901 |
| Nov 3, 2005 | St. Jude Medical / Daig Division Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Terminated |
DYB | K884494 |
| Sep 21, 2005 | Enpath Medical, Inc. Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tippe Terminated |
DYB | K043489 |
| Aug 30, 2005 | Guidant Corporation Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc Terminated |
DYB | K831751 |
| Aug 30, 2005 | Guidant Corporation Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one tunneler and four sheaths. Sterilized with gaseous ethylene oxide. Guidant Corporation, Car Terminated |
DYB | None listed |
| Aug 30, 2005 | Guidant Corporation Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN Terminated |
DYB | None listed |
| Aug 24, 2005 | Guidant Cardiac Surgery Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button. Terminated |
DYB | None listed |
| Aug 3, 2005 | B. Braun Medical, Inc. Locking Tear-Away Sheath Introducer Product Line.
ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/;
P560K PICC 5FR W/INTRO KIT;
MTI451845 4.5FR MINI T/A;
MTI551845 5.5FR MINI TA;
MTI651845 6.5FR MINI T/A;
P Terminated |
DYB | K871152 K871153 +3 |
| Jul 20, 2005 | Boston Scientific Corp EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801 Terminated |
DYB | None listed |
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