Cleared Traditional

DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 (K894131) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894131 · Thermedics, Inc. · Cardiovascular device
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Sep 1989
Decision
105d
Days
Class 2
Risk

K894131 is an FDA 510(k) clearance for the DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Thermedics, Inc. (Woburn, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermedics, Inc. devices

Submission Details

510(k) Number K894131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1989
Decision Date September 26, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 302
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K894131.
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989
USCI CORONARY INFUSION CATHETER
K891069 · C.R. Bard, Inc. · Aug 1989