PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

MEDTRONICS INTERVENTIONAL VASCULAR

The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Piton(tm) Y-pack And Piton(tm) Tri-pack).

Pre-market Notification Details

• Device ID: K945461
• 510k Number: K945461
• Device Name: PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
• Classification: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
• Applicant: MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923
• Contact: Joseph O Magliozzi
• Correspondent: Joseph O Magliozzi; MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923
• Product Code: DTL
• CFR Regulation Number: 870.4290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-07
• Decision Date: 1995-02-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20643169002962	K945461	000
20643169843107	K945461	000
20643169843060	K945461	000
00681490225922	K945461	000