The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Protectiv Acuvance Iv Catheter System.
| Device ID | K012128 |
| 510k Number | K012128 |
| Device Name: | PROTECTIV ACUVANCE IV CATHETER SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Katie Fordyce |
| Correspondent | Katie Fordyce ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-09 |
| Decision Date | 2001-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688071567 | K012128 | 000 |
| 30351688071389 | K012128 | 000 |
| 30351688071402 | K012128 | 000 |
| 30351688071419 | K012128 | 000 |
| 30351688071426 | K012128 | 000 |
| 50351688071437 | K012128 | 000 |
| 50351688071444 | K012128 | 000 |
| 30351688071457 | K012128 | 000 |
| 50351688071468 | K012128 | 000 |
| 30351688071501 | K012128 | 000 |
| 30351688071525 | K012128 | 000 |
| 30351688071549 | K012128 | 000 |
| 30351688071556 | K012128 | 000 |
| 30351688071372 | K012128 | 000 |