The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Bd Nexiva Closed Iv Catheter System.
Device ID | K102520 |
510k Number | K102520 |
Device Name: | BD NEXIVA CLOSED IV CATHETER SYSTEM |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | Justice Alder |
Correspondent | Justice Alder BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-02 |
Decision Date | 2011-01-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903835404 | K102520 | 000 |
50382903835114 | K102520 | 000 |
50382903835121 | K102520 | 000 |
50382903835169 | K102520 | 000 |
50382903835176 | K102520 | 000 |
50382903835183 | K102520 | 000 |
50382903835190 | K102520 | 000 |
50382903835206 | K102520 | 000 |
50382903835305 | K102520 | 000 |
50382903835312 | K102520 | 000 |
50382903835329 | K102520 | 000 |
50382903835367 | K102520 | 000 |
50382903835374 | K102520 | 000 |
50382903835381 | K102520 | 000 |
50382903835398 | K102520 | 000 |
50382903835107 | K102520 | 000 |