The following data is part of a premarket notification filed by Medsource International, Llc. with the FDA for Medsource Iv Safety Catheter.
| Device ID | K131555 |
| 510k Number | K131555 |
| Device Name: | MEDSOURCE IV SAFETY CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. Mound, MN 55364 |
| Contact | Jennifer Ness |
| Correspondent | Jennifer Ness MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. Mound, MN 55364 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2014-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816703021958 | K131555 | 000 |
| 00816703020678 | K131555 | 000 |
| 00816703020661 | K131555 | 000 |
| 00840155406544 | K131555 | 000 |
| 00840155406506 | K131555 | 000 |
| 00840155406476 | K131555 | 000 |
| 00840155406445 | K131555 | 000 |
| 00840155406414 | K131555 | 000 |
| 00840155406384 | K131555 | 000 |
| 00840155406360 | K131555 | 000 |
| 00840155406322 | K131555 | 000 |
| 00840155406308 | K131555 | 000 |
| 00840155406278 | K131555 | 000 |
| 00816703020685 | K131555 | 000 |
| 00816703020692 | K131555 | 000 |
| 00816703020708 | K131555 | 000 |
| 00816703021941 | K131555 | 000 |
| 00816703020814 | K131555 | 000 |
| 00816703020807 | K131555 | 000 |
| 00816703020791 | K131555 | 000 |
| 00816703020784 | K131555 | 000 |
| 00816703020777 | K131555 | 000 |
| 00816703020760 | K131555 | 000 |
| 00816703020753 | K131555 | 000 |
| 00816703020746 | K131555 | 000 |
| 00816703020739 | K131555 | 000 |
| 00816703020722 | K131555 | 000 |
| 00816703020715 | K131555 | 000 |
| 00840155406230 | K131555 | 000 |