ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.

Cannula, Catheter

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Additional Letter Designation For Aortic Arch Can..

Pre-market Notification Details

• Device ID: K870826
• 510k Number: K870826
• Device Name: ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.
• Classification: Cannula, Catheter
• Applicant: SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714
• Contact: Morton Barak
• Correspondent: Morton Barak; SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714
• Product Code: DQR
• CFR Regulation Number: 870.1300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-03-03
• Decision Date: 1987-03-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
38033178000353	K870826	000
38033178000537	K870826	000
38033178000544	K870826	000
38033178000551	K870826	000
38033178000605	K870826	000
38033178000612	K870826	000
38033178000629	K870826	000
38033178000636	K870826	000
38033178000643	K870826	000
38033178000650	K870826	000
38033178000513	K870826	000
38033178000506	K870826	000
38033178000360	K870826	000
38033178000377	K870826	000
38033178000391	K870826	000
38033178000407	K870826	000
38033178000414	K870826	000
38033178000469	K870826	000
38033178000476	K870826	000
38033178000483	K870826	000
38033178000490	K870826	000
38033178001091	K870826	000
38033178001107	K870826	000
38033178001626	K870826	000
38033178001633	K870826	000
38033178003026	K870826	000
38033178003163	K870826	000
38033178003170	K870826	000
38033178003309	K870826	000
38033178003316	K870826	000
38033178008489	K870826	000
38033178008526	K870826	000
38033178001619	K870826	000
38033178001602	K870826	000
38033178001114	K870826	000
38033178001442	K870826	000
38033178001459	K870826	000
38033178001466	K870826	000
38033178001473	K870826	000
38033178001480	K870826	000
38033178001497	K870826	000
38033178001589	K870826	000
38033178001596	K870826	000
38033178008540	K870826	000