510(k) K932198
K932198 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH". The FDA issued a decision of Substantially Equivalent (kit) on May 2, 1994. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- May 2, 1994
- Date Received
- May 6, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type