Coaxial Dilator Set

510(k) K000737

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 · Traditional	NumberK000737	Date1 Aug 2000Cleared	StatusActive

5 recalls · 2 ongoing · FDA

- Ongoing Z-2917-2026 FDA Class II initiated 26 Jun 2026 on shared 510(k) K000737
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
- Ongoing Z-1732-2025 FDA Class II initiated 27 Mar 2025
Due to a potential open seal in the sterile barrier packaging .
2 recalls, same reason
- Terminated Z-2561-2018 FDA Class II initiated 2 May 2018
- Terminated Z-2564-2018 FDA Class II initiated 2 May 2018 on shared 510(k) K000737
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
- Terminated Z-1592-2010 FDA Unclassified (pre-2012) initiated 8 Feb 2010
Potential problem with pouch seal thus affecting sterile product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)