The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Catheter, Intravascular Or Percutaneous.
| Device ID | K951078 |
| 510k Number | K951078 |
| Device Name: | CATHETER, INTRAVASCULAR OR PERCUTANEOUS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa J Stone |
| Correspondent | Lisa J Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586016442 | K951078 | 000 |
| 30610586016435 | K951078 | 000 |
| 30610586016428 | K951078 | 000 |
| 30610586016411 | K951078 | 000 |
| 30610586016534 | K951078 | 000 |