510(k) K880860
K880860 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015". The FDA issued a decision of Substantially Equivalent on May 26, 1988. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Dlp, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1988
- Date Received
- March 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Occluder, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.1370
- Review Panel
- CV
- Submission Type