Cleared Traditional

K874465 - SORENSON THERMO. FLOW-DIRECT TRANS PACE...

K874465 is an FDA 510(k) clearance for SORENSON THERMO. FLOW-DIRECT TRANS PACE..., manufactured by Abbott Laboratories. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K874465 · Abbott Laboratories · Cardiovascular device
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May 1988
Decision
208d
Days
Class 2
Risk

K874465 is an FDA 510(k) clearance for the SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 25, 1988 after a review of 208 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K874465

510(k) Number K874465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1987
Decision Date May 25, 1988
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 57
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K874465.
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