Cleared Traditional

K932619 - TRANSSEPTAL INTRODUCER SET

K932619 is the FDA 510(k) clearance for TRANSSEPTAL INTRODUCER SET by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K932619 · Thomas Medical Products, Inc. · Cardiovascular device
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Aug 1993
Decision
84d
Days
Class 2
Risk

K932619 is an FDA 510(k) clearance for the TRANSSEPTAL INTRODUCER SET. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 84 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 Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K932619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1993
Decision Date August 24, 1993
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 519
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