510(k) K875323
K875323 is an FDA 510(k) premarket notification submitted by Schneider-Shilley (Usa) for the device "MODIFIED SCHNEIDER-SHILEY WIRE TORQUER". The FDA issued a decision of Substantially Equivalent on March 28, 1988. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Schneider-Shilley (Usa) has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1988
- Date Received
- December 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type