510(k) K850337
K850337 is an FDA 510(k) premarket notification submitted by Marwood Medical, Inc. for the device "CARDIAC CATHETERIZATION PACK". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Marwood Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1985
- Date Received
- January 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type