SUGITA TITANIUM ANEURYSM CLIP— 510(k) K990202
Substantially EquivalentMizuho America, Inc.
FDA 510(k) clearance K990202 for SUGITA TITANIUM ANEURYSM CLIP, Substantially Equivalent on 1999-06-04. Applicant: Mizuho America, Inc.. Device class: 2.
Clearance details
- Applicant
- Mizuho America, Inc.
- 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
- Rockville, MD, US
Recent devices under product code HCH
view allMore clearances from Mizuho America, Inc.
view allRecalls naming K990202
K-number listed on FDA's recall record- Z-0377-2014 — Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
- Z-0378-2014 — Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990202.
Data sourced from openFDA. This site is unofficial and independent of the FDA.