The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for The Robicsek - Pruitt Aortic Balloon Occlusion Kit.
Device ID | K872090 |
510k Number | K872090 |
Device Name: | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT |
Classification | Occluder, Catheter Tip |
Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Mark R Waddell |
Correspondent | Mark R Waddell IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | DQT |
CFR Regulation Number | 870.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-01 |
Decision Date | 1987-10-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840663101528 | K872090 | 000 |
00840663101511 | K872090 | 000 |