The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Acuvance Plus Safety Iv Catheter, Protectiv Plus Safety Iv Catheter, Optiva Iv Catheter.
| Device ID | K030571 |
| 510k Number | K030571 |
| Device Name: | ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER |
| 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 | 2003-02-24 |
| Decision Date | 2003-03-28 |
| Summary: | summary |