L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS— 510(k) K081489
Substantially EquivalentPeter Lazic GmbH
FDA 510(k) clearance K081489 for L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS, Substantially Equivalent on 2008-09-25. Applicant: Peter Lazic GmbH. Device class: 2.
Clearance details
- Applicant
- Peter Lazic GmbH
- Product code
- Code HCH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5200
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mühlheim An Der Donau, DE
Recent devices under product code HCH
view allRecalls naming K081489
K-number listed on FDA's recall record- Z-1287-2024 — L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
- Z-1288-2024 — L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081489.
Data sourced from openFDA. This site is unofficial and independent of the FDA.