Cleared Traditional

K810029 - REGULATOR VENOSET W/0.22 MICRON IVEX

K810029 · Abbott Laboratories · General Hospital
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Jan 1981
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K810029 is an FDA 510(k) clearance for the REGULATOR VENOSET W/0.22 MICRON IVEX.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 6, 1981.

This device falls under the General Hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K810029

510(k) Number K810029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 06, 1981
Decision Date January 06, 1981
Days to Decision -
Submission Type Traditional
Review Panel General Hospital (HO)
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 -