Cleared Traditional

K790014 - BIPOLAR

K790014 is an FDA 510(k) clearance for BIPOLAR, manufactured by Cordis Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K790014 · Cordis Corp. · Cardiovascular device
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Feb 1979
Decision
36d
Days
Class 3
Risk

K790014 is an FDA 510(k) clearance for the BIPOLAR, STANICOR LAMBDA MODEL 236,235. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 36 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 Cordis Corp. devices

FDA 510(k) Submission Details - K790014

510(k) Number K790014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1979
Decision Date February 08, 1979
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 353
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K790014.
MICROLITH MODELS 505
K790432 · Cardiac Pacemakers, Inc. · Mar 1979
MINILITH AND MICROLITH
K790276 · Cardiac Pacemakers, Inc. · Feb 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · Telectronics, Inc. · Feb 1979
ISOLATION SLEEVE, MODEL 349-01
K790098 · Intermedics, Inc. · Jan 1979
ISOLATION SLEEVE, MODEL 347-01
K790099 · Intermedics, Inc. · Jan 1979
ISOLATION SLEEVE, MODEL 348-01
K790100 · Intermedics, Inc. · Jan 1979