Cath-Finder

510(k) K931073

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

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	NumberK931073	Date5 May 1994Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0066-2007 FDA Unclassified (pre-2012) initiated 27 Sep 2006 on shared 510(k) K931073
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.
3 recalls, same reason
- Terminated Z-0804-06 FDA Unclassified (pre-2012) initiated 29 Mar 2006 on shared 510(k) K931073
- Terminated Z-0801-06 FDA Unclassified (pre-2012) initiated 29 Mar 2006 on shared 510(k) K931073
- Terminated Z-0800-06 FDA Unclassified (pre-2012) initiated 29 Mar 2006 on shared 510(k) K931073
One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.

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)