Cleared Traditional

K002094 - BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE (FDA 510(k) Clearance)

K002094 · C.R. Bard, Inc. · Gastroenterology & Urology device

Oct 2000

Decision

87d

Days

Class 2

Risk

K002094 is an FDA 510(k) clearance for the BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on October 6, 2000, 87 days after receiving the submission on July 11, 2000.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number	K002094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 11, 2000
Decision Date	October 06, 2000
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF