Cleared Traditional

K912773 - UNIPOLAR UPSIZING ADAPTOR

K912773 is an FDA 510(k) clearance for UNIPOLAR UPSIZING ADAPTOR, manufactured by Telectronics Pacing Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K912773 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Oct 1991
Decision
121d
Days
Class 2
Risk

K912773 is an FDA 510(k) clearance for the UNIPOLAR UPSIZING ADAPTOR. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Telectronics Pacing Systems, Inc. devices

FDA 510(k) Submission Details - K912773

510(k) Number K912773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date October 23, 1991
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 95
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K912773.
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · Telectronics Pacing Systems, Inc. · May 1994
MISCELLANEOUS PACING LEAD
K925168 · Oscor Medical Corp. · May 1994
MODEL 6984M LEAD EXTENDER KIT
K915724 · Medtronic Vascular · Feb 1992
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142 · Biotronik, GmbH & Co. · Aug 1991
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · Medtronic Vascular · Jul 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · Medtronic Vascular · Apr 1991