NAMIC PTCA Y-ADAPTOR

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

NORTH AMERICAN INSTRUMENT CORP.

The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Ptca Y-adaptor.

Pre-market Notification Details

• Device ID: K900652
• 510k Number: K900652
• Device Name: NAMIC PTCA Y-ADAPTOR
• Classification: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
• Applicant: NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801
• Contact: E Franklin
• Correspondent: E Franklin; NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801
• Product Code: DTL
• CFR Regulation Number: 870.4290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-02-09
• Decision Date: 1990-06-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10193489087819	K900652	000
10193489058918	K900652	000
20193489058878	K900652	000
20193489058861	K900652	000
20193489058854	K900652	000
20193489058847	K900652	000
20193489069324	K900652	000
20193489069300	K900652	000
20193489069294	K900652	000
20193489069270	K900652	000
20193489069256	K900652	000
20193489069249	K900652	000
10193489058925	K900652	000
20193489058915	K900652	000
10193489067996	K900652	000
10193489067989	K900652	000
10193489067972	K900652	000
10193489067125	K900652	000
10193489067118	K900652	000
20193489087823	K900652	000
20193489069317	K900652	000
20193489069287	K900652	000
20193489069263	K900652	000
20193489069232	K900652	000
20193489058922	K900652	000
30193489103490	K900652	000