Cleared Traditional

K790221 - PULSE GENERATOR

K790221 · Intermedics, Inc. · Cardiovascular device
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Jan 1979
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K790221 is an FDA 510(k) clearance for the PULSE GENERATOR, CYBERLITH IMPLANTABLE.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1979.

This device falls under the Cardiovascular FDA review panel. 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 - K790221

510(k) Number K790221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 30, 1979
Decision Date January 30, 1979
Days to Decision -
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -