Cleared Traditional

K863446 - ANGIOMED HIGH PRESSURE CONNECTORS
(FDA 510(k) Clearance)

K863446 · Angiomed U.S., Inc. · General & Plastic Surgery device

Sep 1986

Decision

15d

Days

Class 1

Risk

K863446 is an FDA 510(k) clearance for the ANGIOMED HIGH PRESSURE CONNECTORS. This device is classified as a Connector, Catheter (Class I - General Controls, product code GCD).

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on September 23, 1986, 15 days after receiving the submission on September 8, 1986.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K863446 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1986
Decision Date	September 23, 1986
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—