Cleared Traditional

K790983 - BIFLEX TM TEMPORARY PACING PROBE

K790983 is the FDA 510(k) clearance for BIFLEX TM TEMPORARY PACING PROBE by Advanced Medical Concepts, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K790983 · Advanced Medical Concepts, Inc. · Cardiovascular device
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Jul 1979
Decision
46d
Days
Class 3
Risk

K790983 is an FDA 510(k) clearance for the BIFLEX TM TEMPORARY PACING PROBE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Advanced Medical Concepts, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1979 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 Advanced Medical Concepts, Inc. devices

Submission Details

510(k) Number K790983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1979
Decision Date July 10, 1979
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 273
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K790983.
MODEL 482-01 BIPOLAR COAXIAL PACING LEAD
K791378 · Intermedics, Inc. · Sep 1979
MEDTRONIC MODELS 69914/699OU
K791667 · Medtronic Vascular · Sep 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
K791552 · Pacesetter Systems · Sep 1979
MEDTRONIC MODEL 6957
K790429 · Medtronic Vascular · Jul 1979
MODEL 6971 W/ DBS WIRE
K790988 · Medtronic Vascular · Jun 1979
ENDOCARDIAL PACING LEAD, MODEL 476-01
K790548 · Intermedics, Inc. · Jun 1979