510(k) K812325
K812325 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "INTK-08 8 FRENCH INTRODUCER KIT W/SIDE". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Sorensen Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1981
- Date Received
- August 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type