Cleared Traditional

K770016 - PACING KIT, ELECATH TRANSTHORACIC

K770016 is an FDA 510(k) clearance for PACING KIT, manufactured by Electro-Catheter Corp.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K770016 · Electro-Catheter Corp. · Cardiovascular device
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Jan 1977
Decision
10d
Days
Class 2
Risk

K770016 is an FDA 510(k) clearance for the PACING KIT, ELECATH TRANSTHORACIC. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1977 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 Electro-Catheter Corp. devices

FDA 510(k) Submission Details - K770016

510(k) Number K770016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1977
Decision Date January 14, 1977
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 83
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K770016.
PAD, COOLING #27-999
K781764 · Cobe Laboratories, Inc. · Dec 1978
HEAT EXCHANGER, FHX-14
K781210 · Delta Medical Industries · Oct 1978
HEAT EXCHANGER, DISP., OMNITHERM
K772117 · Scimed Life Systems, Inc. · Mar 1978
PACING KIT, TRANSMYOCARDIAL
K770017 · Electro-Catheter Corp. · Jan 1977
PACING KIT, SEMI-FLOATING
K770018 · Electro-Catheter Corp. · Jan 1977