Cleared Traditional

K897067 - MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES

K897067 is an FDA 510(k) clearance for MODIFIED J-STIFFENER WIRE MATERIAL IN L..., manufactured by Telectronics Pacing Systems, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K897067 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Feb 1990
Decision
46d
Days
Class 3
Risk

K897067 is an FDA 510(k) clearance for the MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on February 5, 1990 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 - K897067

510(k) Number K897067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1989
Decision Date February 05, 1990
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 420
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K897067.
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · Pacesetter Systems · Apr 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · Medtronic Vascular · Mar 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136 · Medtronic Vascular · Feb 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528 · Daig Corp. · Jan 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · Pacesetter Systems · Dec 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · Possis Medical, Inc. · Dec 1989