510(k) K942457
K942457 is an FDA 510(k) premarket notification submitted by Intramed Laboratories, Inc. for the device "GRAFT THROMBECTOMY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Intramed Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1995
- Date Received
- May 24, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type