510(k) K923245
K923245 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "TRIGUIDE-PLUS GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on Feb 12, 1993. The device falls under product code DQY (Catheter, Percutaneous), 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 12, 1993
- Date Received
- Jul 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)