510(k) K960312
K960312 is an FDA 510(k) premarket notification submitted by R D Intl. for the device "RDI CARDIAC INSULATION PAD". The FDA issued a decision of Substantially Equivalent on April 19, 1996. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. R D Intl. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1996
- Date Received
- January 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, Surgical
- Device Class
- Class II
- Regulation Number
- 870.4475
- Review Panel
- CV
- Submission Type