Cleared Traditional

K940545 - SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX ...

K940545 is the FDA 510(k) clearance for SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX ... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K940545 · Scimed Life Systems, Inc. · Cardiovascular device
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May 1994
Decision
88d
Days
Class 2
Risk

K940545 is an FDA 510(k) clearance for the SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 6, 1994 after a review of 88 days - a notably fast clearance cycle.

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: 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 K940545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date May 06, 1994
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 581
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K940545.
7 FRENCH LARGE LUMEN TRIGUIDE-PLUS
K943783 · Scimed Life Systems, Inc. · Oct 1994
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K940559 · Advanced Cardiovascular Systems, Inc. · May 1994
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K940603 · Scimed Life Systems, Inc. · Apr 1994
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K934685 · Mallinckrodt Medical · Apr 1994