Product code MGB ยท Class 3
Device, Hemostasis, Vascular
0510(k)s in 12 months (0 all time)
0recalls in 12 months (12 all time)
0recalls that name a 510(k)
Top companies in MGB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cordis US Corp | 0 | 2 |
| St. Jude Medical / Daig Division | 0 | 2 |
| Abbott Vascular | 0 | 1 |
| Abbott Vascular-Cardiac Therapies dba Guidant Corporation | 0 | 1 |
| AccessClosure, Inc., A Cardinal Health Company | 0 | 1 |
| Cordis Corporation | 0 | 1 |
| Datascope Collagen Products Division | 0 | 1 |
| EXP Pharmaceutical Services Corp | 0 | 1 |
| TELEFLEX LLC | 0 | 1 |
| Terumo Medical Corp | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Cordis US Corp MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites Open, Classified |
MGB | None listed |
| Jan 5, 2024 | Cordis US Corp MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. Open, Classified |
MGB | None listed |
| May 18, 2023 | TELEFLEX LLC Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen Open, Classified |
MGB | None listed |
| Apr 9, 2018 | Terumo Medical Corp Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 Terminated |
MGB | None listed |
| Feb 10, 2017 | Abbott Vascular StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02.
The UDI is 08717648079467.
The GMDN is 47411. Terminated |
MGB | None listed |
| Aug 3, 2016 | AccessClosure, Inc., A Cardinal Health Company 6F/7F MynxGrip Vascular Closure Device;
Product Model MX6721,
Product Usage:
The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites w Terminated |
MGB | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 610130.
EXP (repackager), St. Jude Medical (OEM)
Device, Terminated |
MGB | None listed |
| Jan 25, 2013 | Cordis Corporation Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambu Terminated |
MGB | None listed |
| Jul 6, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization. Terminated |
MGB | None listed |
| Nov 7, 2006 | St. Jude Medical / Daig Division The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size. Terminated |
MGB | None listed |
| Mar 25, 2006 | St. Jude Medical / Daig Division Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA. Terminated |
MGB | None listed |
| Jul 20, 2004 | Datascope Collagen Products Division VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. ind Terminated |
MGB | None listed |
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