The following data is part of a premarket notification filed by Gerard Medical, Inc. with the FDA for Catheter Tunneler.
| Device ID | K972555 |
| 510k Number | K972555 |
| Device Name: | CATHETER TUNNELER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | GERARD MEDICAL, INC. 6 CITY DEPOT RD. P.O. BOX 940 Charlton City, MA 01508 |
| Contact | Richard Cayer |
| Correspondent | Richard Cayer GERARD MEDICAL, INC. 6 CITY DEPOT RD. P.O. BOX 940 Charlton City, MA 01508 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-07 |
| Decision Date | 1997-12-22 |
| Summary: | summary |