510(k) K801637
K801637 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code KPK (Marker, Ostia, Aorto-Saphenous Vein), a Class II device regulated under 21 CFR 878.4650. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1980
- Date Received
- July 17, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ostia, Aorto-Saphenous Vein
- Device Class
- Class II
- Regulation Number
- 878.4650
- Review Panel
- CV
- Submission Type