The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Gesco Per-q-cath Midline Catheters.
| Device ID | K971991 |
| 510k Number | K971991 |
| Device Name: | GESCO PER-Q-CATH MIDLINE CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Jane Ann Martin |
| Correspondent | Jane Ann Martin BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-11-07 |
| Summary: | summary |