510(k) K875064
K875064 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED INFLATION DEVICE, MODEL SM 2000". The FDA issued a decision of Substantially Equivalent on Feb 29, 1988. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 29, 1988
- Date Received
- Dec 9, 1987
- 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
- 510(k)