MODIFIED USE OF PULL-APART INTRODUCER SET

Catheter, Peritoneal Dialysis, Single Use

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Use Of Pull-apart Introducer Set.

Pre-market Notification Details

• Device ID: K871730
• 510k Number: K871730
• Device Name: MODIFIED USE OF PULL-APART INTRODUCER SET
• Classification: Catheter, Peritoneal Dialysis, Single Use
• Applicant: QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121
• Contact: Mayr-lee Donoghue
• Correspondent: Mayr-lee Donoghue; QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121
• Product Code: FKO
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-05-05
• Decision Date: 1987-05-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884521024318	K871730	000
20884521024301	K871730	000
20884521024295	K871730	000
20884521024288	K871730	000