The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Per-q-cath Mid-line.
| Device ID | K954422 |
| 510k Number | K954422 |
| Device Name: | PER-Q-CATH MID-LINE |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | GESCO INTL., INC. 232 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Matthew Nowland |
| Correspondent | Matthew Nowland GESCO INTL., INC. 232 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-21 |
| Decision Date | 1995-12-15 |