510(k) K840671
K840671 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "CARDIAC CATHETERIZATION PACK". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Professional Medical Services has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1984
- Date Received
- February 21, 1984
- 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