Cleared Traditional

K972112 - INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (FDA 510(k) Clearance)

K972112 · Taut, Inc. · General & Plastic Surgery device

Dec 1997

Decision

179d

Days

Class 1

Risk

K972112 is an FDA 510(k) clearance for the INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450. This device is classified as a Catheter, Peritoneal (Class I - General Controls, product code GBW).

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on December 1, 1997, 179 days after receiving the submission on June 5, 1997.

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

Submission Details

510(k) Number	K972112 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 05, 1997
Decision Date	December 01, 1997
Days to Decision	179 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement