510(k) K881197
K881197 is an FDA 510(k) premarket notification submitted by Schneider-Shilley (Usa) for the device "SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on May 16, 1988. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Schneider-Shilley (Usa) has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1988
- Date Received
- March 21, 1988
- Clearance Type
- Traditional
- 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