Guider Softip Guiding Catheter Xf 5F

510(k) K010853

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK010853	Date18 Apr 2001Cleared	StatusActive

17 recalls · 1 ongoing · FDA

- Ongoing Z-1582-2022 FDA Class II initiated 9 Aug 2022
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
- Terminated Z-2735-2018 FDA Class II initiated 11 Dec 2017
Potential polymer material degradation.
15 recalls, same reason
- Terminated Z-0338-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0337-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0343-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0340-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0333-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0336-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0345-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0335-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0339-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0346-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0344-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0334-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0341-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0347-2017 FDA Class II initiated 5 Oct 2016
- Terminated Z-0342-2017 FDA Class II initiated 5 Oct 2016
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.

1 jurisdiction

United States — FDA 510(k) Active

510(k)