510(k) K020854
K020854 is an FDA 510(k) premarket notification submitted by Jomed AG for the device "MODIFICATION TO FOX PTA CATHETER". The FDA issued a decision of Substantially Equivalent on April 11, 2002. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Jomed AG has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2002
- Date Received
- March 15, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type