510(k) K910916
K910916 is an FDA 510(k) premarket notification submitted by Cathlab Corp. for the device "CATHLAB SILICONE OCCLUSION BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Cathlab Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1991
- Date Received
- March 5, 1991
- 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