Cleared Traditional

K864326 - MODEL 366-13 ADAPTAID STEP DOWN ADAPTER

K864326 is an FDA 510(k) clearance for MODEL 366-13 ADAPTAID STEP DOWN ADAPTER, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K864326 · Intermedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
73d
Days
Class 3
Risk

K864326 is an FDA 510(k) clearance for the MODEL 366-13 ADAPTAID STEP DOWN ADAPTER. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on January 16, 1987 after a review of 73 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K864326

510(k) Number K864326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date January 16, 1987
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K864326.
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
K870610 · Telectronics, Inc. · Mar 1987
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · Pacesetter Systems · Mar 1987
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
K870034 · Oscor Medical Corp. · Mar 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · Intermedics, Inc. · Jan 1987
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · Cardiac Control Systems, Inc. · Jan 1987