The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Flexcel Carotid Shunt (inlying), Model 2020-05.
| Device ID | K071367 |
| 510k Number | K071367 |
| Device Name: | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Minnie Mildwoff |
| Correspondent | Minnie Mildwoff LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-16 |
| Decision Date | 2007-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663101429 | K071367 | 000 |
| 00840663101405 | K071367 | 000 |
| 00840663101382 | K071367 | 000 |
| 00840663101368 | K071367 | 000 |
| 00840663101344 | K071367 | 000 |