The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Nexiva Closed Iv Catheter System (single Port) With Maxzero Needleless Connector.
| Device ID | K170336 |
| 510k Number | K170336 |
| Device Name: | BD Nexiva Closed IV Catheter System (Single Port) With MaxZero Needleless Connector |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Becton, Dickinson And Company 9450 South State Street Sandy, UT 84070 |
| Contact | Kimberly Geisler |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-02-02 |
| Decision Date | 2017-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903835602 | K170336 | 000 |
| 50382903835596 | K170336 | 000 |
| 50382903835589 | K170336 | 000 |
| 50382903835572 | K170336 | 000 |
| 50382903835565 | K170336 | 000 |
| 50382903835527 | K170336 | 000 |
| 50382903835510 | K170336 | 000 |
| 50382903835503 | K170336 | 000 |