PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)

Catheter, Intravascular Occluding, Temporary

LEMAITRE VASCULAR, INC.

The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Pruitt F3 Outlying And Inlying Carotid Shunt (with And Without T-port).

Pre-market Notification Details

• Device ID: K051067
• 510k Number: K051067
• Device Name: PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
• Classification: Catheter, Intravascular Occluding, Temporary
• Applicant: LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Contact: Amy Watzke
• Correspondent: Amy Watzke; 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: 2005-04-26
• Decision Date: 2005-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840663101320	K051067	000
00840663101207	K051067	000
00840663101214	K051067	000
00840663101221	K051067	000
00840663101238	K051067	000
00840663101245	K051067	000
00840663101252	K051067	000
00840663101269	K051067	000
00840663101276	K051067	000
00840663101283	K051067	000
00840663101290	K051067	000
00840663101306	K051067	000
00840663101313	K051067	000
00840663101191	K051067	000