Cleared Traditional

K951089 - SCIMED GATEWAY PLUS

K951089 is the FDA 510(k) clearance for SCIMED GATEWAY PLUS by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K951089 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
83d
Days
Class 2
Risk

K951089 is an FDA 510(k) clearance for the SCIMED GATEWAY PLUS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on May 31, 1995 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K951089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date May 31, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 65
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K951089.
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K934123 · Merit Medical Systems, Inc. · Nov 1993
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K922840 · Gish Biomedical, Inc. · May 1993