Cleared Traditional

K790218 - BIPOLAR LEAD ADAPTOR

K790218 is the FDA 510(k) clearance for BIPOLAR LEAD ADAPTOR by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K790218 · Pacesetter Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
192d
Days
Class 2
Risk

K790218 is an FDA 510(k) clearance for the BIPOLAR LEAD ADAPTOR, MODEL BA-415. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 192 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 Pacesetter Systems devices

Submission Details

510(k) Number K790218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1979
Decision Date August 10, 1979
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 84
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K790218.
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
K801038 · Intermedics, Inc. · Jul 1980
GE LEAD ADAPTER, MODEL 345-01
K801040 · Intermedics, Inc. · Jun 1980
ADAPTER KIT
K800353 · Daig Corp. · May 1980
ELECTRODE, MODEL 030-324
K781822 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-326
K781823 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-324/4 GUAGE
K781824 · Telectronics, Inc. · Feb 1979