The following data is part of a premarket notification filed by Strato/infusaid, Inc. with the FDA for Strato/infusaid Tunneler.
| Device ID | K950987 |
| 510k Number | K950987 |
| Device Name: | STRATO/INFUSAID TUNNELER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Contact | Craig M Audet |
| Correspondent | Craig M Audet STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-06-02 |