The following data is part of a premarket notification filed by Tni Manufacturing, Inc. with the FDA for Intermediate Catheter, 105 Cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm.
| Device ID | K152202 |
| 510k Number | K152202 |
| Device Name: | Intermediate Catheter, 105 Cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm |
| Classification | Catheter, Percutaneous |
| Applicant | TNI Manufacturing, Inc. 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Contact | Daniel Sablyak |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-08-06 |
| Decision Date | 2015-12-14 |
| Summary: | summary |