510(k) K980453 ยท DQY Catheter, Percutaneous
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
| Applicant | Boston Scientific Scimed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 11, 1998 |
| Received | Feb 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980453
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2022 | Boston Scientific Corporation Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 Open, Classified |
DQY | None listed |
| Dec 11, 2017 | Boston Scientific Corporation Boston Scientific Guider Softip XF Guide Catheter
Product Usage:
Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed wit Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devic Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/MP XF/8FR/100 cm, Model number: M003101480.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/MP XF/7FR/90CM, Model number: H965100470.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/MP XF/6FR/90CM, Model number: H965100460.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/ST XF/8FR/90CM, Model number: H965100520.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40DEG XF/6FR/90CM, Model number: H965100420.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional device Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER MPXF 5F 100CM, Model number: M003101630.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices in Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional dev Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40XF/8FR/90CM, Model number: H965100440 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional de Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/ST XF/6FR/100 cm, Model number:M003101500 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER MPXF 5F 90CM, Model number: M003100630.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices int Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER STRAIGHT XF 5F 90CM, Model number: .
M003100640.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional dev Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devi Terminated |
DQY | None listed |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER 40XF 5F 90CM, Model number:M003100620 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices int Terminated |
DQY | None listed |
| Nov 20, 2009 | Boston Scientific Corporation Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA.
The device is intended to facilitate placem Terminated |
DQY | None listed |
| Nov 24, 2007 | Boston Scientific Target Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymout Terminated |
DQY | None listed |
| Nov 24, 2007 | Boston Scientific Target Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.