MEDTRONIC INPUT PS INTRODUCER

Introducer, Catheter

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Input Ps Introducer.

Pre-market Notification Details

• Device ID: K132617
• 510k Number: K132617
• Device Name: MEDTRONIC INPUT PS INTRODUCER
• Classification: Introducer, Catheter
• Applicant: MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers, MA 01923
• Contact: Nisarg Shah
• Correspondent: Nisarg Shah; MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers, MA 01923
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-21
• Decision Date: 2014-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20643169116003	K132617	000
00643169014206	K132617	000
20643169014194	K132617	000
20643169014187	K132617	000
20643169014170	K132617	000
20643169014163	K132617	000
20643169014156	K132617	000
20643169014149	K132617	000
20643169014132	K132617	000
20643169014125	K132617	000
20643169014101	K132617	000
20643169014064	K132617	000
20643169014040	K132617	000
20643169014026	K132617	000
20643169014002	K132617	000
20643169013982	K132617	000
20643169013968	K132617	000
20643169014217	K132617	000
20643169014224	K132617	000
20643169115990	K132617	000
20643169115969	K132617	000
20643169115952	K132617	000
20643169014651	K132617	000
20643169014644	K132617	000
20643169014583	K132617	000
20643169014576	K132617	000
20643169014514	K132617	000
20643169014507	K132617	000
20643169014330	K132617	000
20643169014293	K132617	000
20643169014279	K132617	000
20643169014262	K132617	000
20643169014255	K132617	000
20643169014248	K132617	000
20643169014231	K132617	000
00643169620667	K132617	000