Cleared Traditional

K844814 - BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE ...

K844814 is an FDA 510(k) clearance for BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE ..., manufactured by Intermedics, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K844814 · Intermedics, Inc. · Cardiovascular device
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Aug 1985
Decision
261d
Days
Class 2
Risk

K844814 is an FDA 510(k) clearance for the BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 261 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Standard predicate-based submission. Standard predicate reliance. 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 - K844814

510(k) Number K844814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1984
Decision Date August 29, 1985
Days to Decision 261 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
136d slower than avg
Panel avg: 125d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 86
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K844814.
PACEMAKER LEAD ADAPTER
K862656 · Cordis Corp. · Jul 1986
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · Intermedics, Inc. · Mar 1986
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
K854997 · Telectronics, Inc. · Feb 1986
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · Medtronic Vascular · Aug 1985
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
K851897 · Cardiac Control Systems, Inc. · Aug 1985
MEDTRONIC MODEL 5561
K852356 · Medtronic Vascular · Aug 1985