The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Bio-medicus Adult Cannulae And Introducer.
Device ID | K142673 |
510k Number | K142673 |
Device Name: | Bio-Medicus Adult Cannulae And Introducer |
Classification | Catheter, Percutaneous |
Applicant | Medtronic, Inc 8200 Coral Sea St. NE Mounds View, MN 55112 |
Contact | Bruce Backlund |
Correspondent | Bruce Backlund Medtronic, Inc 8200 Coral Sea St. NE Mounds View, MN 55112 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-19 |
Decision Date | 2014-11-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00763000193386 | K142673 | 000 |
00643169025769 | K142673 | 000 |
00643169025752 | K142673 | 000 |
00643169025745 | K142673 | 000 |
00643169025738 | K142673 | 000 |
00763000116286 | K142673 | 000 |
00763000116279 | K142673 | 000 |
00763000116125 | K142673 | 000 |
00763000116118 | K142673 | 000 |
00763000116101 | K142673 | 000 |
00763000116095 | K142673 | 000 |
00763000116088 | K142673 | 000 |
00643169025776 | K142673 | 000 |
00643169025783 | K142673 | 000 |
00763000193379 | K142673 | 000 |
00763000193362 | K142673 | 000 |
00763000193355 | K142673 | 000 |
00643169026001 | K142673 | 000 |
00643169025998 | K142673 | 000 |
00643169025981 | K142673 | 000 |
00643169025974 | K142673 | 000 |
00643169025967 | K142673 | 000 |
00643169025950 | K142673 | 000 |
00643169025943 | K142673 | 000 |
00643169025936 | K142673 | 000 |
00763000116071 | K142673 | 000 |