The following data is part of a premarket notification filed by Footprint Medical Inc. with the FDA for Footprint Medical Polyurethane Picc Catheter.
Device ID | K130507 |
510k Number | K130507 |
Device Name: | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | FOOTPRINT MEDICAL INC. 12727 CIMARRON PATH San Antonio, TX 78249 |
Contact | Clyde N Baker |
Correspondent | Clyde N Baker FOOTPRINT MEDICAL INC. 12727 CIMARRON PATH San Antonio, TX 78249 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-02-27 |
Decision Date | 2013-06-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10858778006109 | K130507 | 000 |
10858778006093 | K130507 | 000 |
10858778006086 | K130507 | 000 |
10858778006079 | K130507 | 000 |
10858778006062 | K130507 | 000 |
10858778006055 | K130507 | 000 |