The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Chocolate Pta Balloon Catheter.
| Device ID | K213631 |
| 510k Number | K213631 |
| Device Name: | Chocolate PTA Balloon Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Medtronic, Inc. 2300 Berkshire Lane North, Suite 5 Plymouth, MN 55441 |
| Contact | Laura Hanson |
| Correspondent | Laura Hanson Medtronic, Inc. 2300 Berkshire Lane North, Suite 5 Plymouth, MN 55441 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2021-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000500238 | K213631 | 000 |
| 00763000500078 | K213631 | 000 |
| 00763000500085 | K213631 | 000 |
| 00763000500092 | K213631 | 000 |
| 00763000500108 | K213631 | 000 |
| 00763000500115 | K213631 | 000 |
| 00763000500122 | K213631 | 000 |
| 00763000500139 | K213631 | 000 |
| 00763000500146 | K213631 | 000 |
| 00763000500153 | K213631 | 000 |
| 00763000500160 | K213631 | 000 |
| 00763000500177 | K213631 | 000 |
| 00763000500184 | K213631 | 000 |
| 00763000500191 | K213631 | 000 |
| 00763000500207 | K213631 | 000 |
| 00763000500214 | K213631 | 000 |
| 00763000500221 | K213631 | 000 |
| 00763000500061 | K213631 | 000 |