The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Telescope Guide Extension Catheter.
| Device ID | K183353 |
| 510k Number | K183353 |
| Device Name: | Telescope Guide Extension Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Medtronic Inc. Parkmore Business Park West Galway, IE |
| Contact | Sharon Fahy |
| Correspondent | Elaine Gullane Medtronic Inc. Parkmore Business Park West Galway, IE |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000156978 | K183353 | 000 |
| 00763000156954 | K183353 | 000 |