510(k) K003519
K003519 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "YASARGIL PERMANENT ANEURYSM CLIPS". The FDA issued a decision of Substantially Equivalent on January 29, 2001. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2001
- Date Received
- November 15, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Aneurysm
- Device Class
- Class II
- Regulation Number
- 882.5200
- Review Panel
- NE
- Submission Type