L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
FDA 510(k) clearance K081489 · decided 2008-09-25
Clearance details
- K-number
- K081489
- Device name
- L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
- Applicant
- Peter Lazic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-05-28
- Decision date
- 2008-09-25
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- HCH
- Device class
- 2
- Regulation number
- 882.5200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mühlheim An Der Donau, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile recall (Z-1287-2024) | Peter Lazic Gmbh | 2024-03-12 |
| L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile recall (Z-1288-2024) | Peter Lazic Gmbh | 2024-03-12 |