8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER

System, Balloon, Intra-aortic And Control

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for 8fr. Narrowflex Universal Intra-aortic Balloon Catheter.

Pre-market Notification Details

• Device ID: K993966
• 510k Number: K993966
• Device Name: 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
• Classification: System, Balloon, Intra-aortic And Control
• Applicant: ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149
• Contact: William Paquin
• Correspondent: William Paquin; ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149
• Product Code: DSP
• CFR Regulation Number: 870.3535 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-23
• Decision Date: 2000-02-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30801902026478	K993966	000
30801902010873	K993966	000
30801902010866	K993966	000
30801902010842	K993966	000
30801902010545	K993966	000
30801902002205	K993966	000
20801902182863	K993966	000
20801902182856	K993966	000
20801902182832	K993966	000