HIGH PRESSURE INJECTION LINES

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

The following data is part of a premarket notification filed by Maxxim Medical with the FDA for High Pressure Injection Lines.

Device ID	K963749
510k Number	K963749
Device Name:	HIGH PRESSURE INJECTION LINES
Classification	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102
Contact	Richard A Hamer
Correspondent	Richard A Hamer MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102
Product Code	DTL
CFR Regulation Number	870.4290 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	1996-09-18
Decision Date	1996-12-17
Summary:	summary