The following data is part of a premarket notification filed by Medrad, Inc. / Bayer Medical Care, Inc. with the FDA for Medrad Twist & Go High Pressure Connector Tubing.
| Device ID | K131517 |
| 510k Number | K131517 |
| Device Name: | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING |
| Classification | Tubing, Fluid Delivery |
| Applicant | MEDRAD, INC. / BAYER MEDICAL CARE, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Lisa A Ewing |
| Correspondent | Lisa A Ewing MEDRAD, INC. / BAYER MEDICAL CARE, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2013-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40616258010074 | K131517 | 000 |
| 40616258010142 | K131517 | 000 |
| 40616258010135 | K131517 | 000 |
| 40616258021728 | K131517 | 000 |
| 40616258021711 | K131517 | 000 |
| 40616258021520 | K131517 | 000 |
| 40616258021513 | K131517 | 000 |
| 40616258021506 | K131517 | 000 |
| 40616258021490 | K131517 | 000 |
| 40616258024828 | K131517 | 000 |
| 40616258010159 | K131517 | 000 |
| 40616258010166 | K131517 | 000 |
| 10616258006946 | K131517 | 000 |
| 10616258007134 | K131517 | 000 |
| 10616258007127 | K131517 | 000 |
| 10616258007110 | K131517 | 000 |
| 10616258007103 | K131517 | 000 |
| 10616258007097 | K131517 | 000 |
| 10616258006984 | K131517 | 000 |
| 10616258006977 | K131517 | 000 |
| 10616258006960 | K131517 | 000 |
| 10616258006953 | K131517 | 000 |
| 40616258024569 | K131517 | 000 |