The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Nitroglycerin Sets With Duo-vent Spike.
Device ID | K150860 |
510k Number | K150860 |
Device Name: | Nitroglycerin Sets With DUO-VENT Spike |
Classification | Set, Administration, Intravascular |
Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
Contact | Dhiraj Bizzul |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2015-04-01 |
Decision Date | 2015-04-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412051845 | K150860 | 000 |
50085412046360 | K150860 | 000 |
50085412019999 | K150860 | 000 |
50085412002755 | K150860 | 000 |