Cleared Traditional

K920530 - INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG

K920530 is an FDA 510(k) clearance for INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K920530 · Intermedics, Inc. · Cardiovascular device
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Mar 1992
Decision
41d
Days
Class 3
Risk

K920530 is an FDA 510(k) clearance for the INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on March 17, 1992 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 - K920530

510(k) Number K920530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date March 17, 1992
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 354
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K920530.
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
K923868 · Cardiac Control Systems, Inc. · May 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · Medtronic Vascular · May 1993
ASTRA T2, ASTRA T4, ASTRA T6
K920601 · Cardiac Pacemakers, Inc. · Oct 1992
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K920157 · Schneider Intl., Ltd. · Mar 1992
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
K905403 · Cook Pacemaker Corp. · Oct 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · Cardiac Control Systems, Inc. · May 1991