510(k) K971990
K971990 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "GESCO PER-Q-CATH PICC CATHETERS". The FDA issued a decision of Substantially Equivalent on November 7, 1997. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1997
- Date Received
- May 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type