510(k) K943777
K943777 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER". The FDA issued a decision of Substantially Equivalent on Oct 13, 1994. 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
- Oct 13, 1994
- Date Received
- Aug 2, 1994
- 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)