The following data is part of a premarket notification filed by Lemaitre Vascular Inc. with the FDA for Phastipp.
Device ID | K212894 |
510k Number | K212894 |
Device Name: | PhasTIPP |
Classification | Stripper, Vein, External |
Applicant | LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 |
Contact | Anurag Gadgil |
Correspondent | Anurag Gadgil LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 |
Product Code | DWQ |
CFR Regulation Number | 870.4885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-10 |
Decision Date | 2022-03-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PHASTIPP 88642536 not registered Live/Pending |
LeMaitre Vascular, Inc. 2019-10-04 |