510(k) K011783
K011783 is an FDA 510(k) premarket notification submitted by Pfm Produkte Fur Die Medizin AG for the device "MULTI-SNARE SET". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Pfm Produkte Fur Die Medizin AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2002
- Date Received
- June 7, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Embolectomy
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type