510(k) K081489 · HCH Clip, Aneurysm
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
| Applicant | Peter Lazic GmbH, Mühlheim An Der Donau, DE |
| Decision | Substantially Equivalent, Sep 25, 2008 |
| Received | May 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2024 | Peter Lazic Gmbh L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile Open, Classified |
HCH | None listed |
| Mar 12, 2024 | Peter Lazic Gmbh L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile Open, Classified |
HCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.