510(k) K813461
K813461 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "PERCUTANEOUS ENTRY NEEDLE, SELDINGER". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1981
- Date Received
- December 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type