510(k) K010853 ยท DQY Catheter, Percutaneous
GUIDER SOFTIP GUIDING CATHETER XF 5F
| Applicant | Boston Scientific, Target, Fremont CA, US |
| Decision | Substantially Equivalent, Apr 18, 2001 |
| Received | Mar 21, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010853
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.