Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter

Catheter, Continuous Flush

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Pulse* Spray Infusion Catheter System, Uni*fuse Infusion Catheter.

Pre-market Notification Details

• Device ID: K163356
• 510k Number: K163356
• Device Name: Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter
• Classification: Catheter, Continuous Flush
• Applicant: ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough, MA 01752
• Contact: Robin Fuller
• Correspondent: Robin Fuller; ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough, MA 01752
• Product Code: KRA
• CFR Regulation Number: 870.1210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-30
• Decision Date: 2017-05-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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