510(k) K910339
K910339 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "AVD INTIMAX OCCLUSION CATHETER". The FDA issued a decision of Substantially Equivalent on May 29, 1991. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1991
- Date Received
- January 28, 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