Cleared Traditional

K840641 - VESSEL DILATOR

K840641 · Aries Medical, Inc. · Cardiovascular device
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Feb 1984
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K840641 is an FDA 510(k) clearance for the VESSEL DILATOR.

Submitted by Aries Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 14, 1984.

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 Aries Medical, Inc. devices

FDA 510(k) Submission Details - K840641

510(k) Number K840641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received February 14, 1984
Decision Date February 14, 1984
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 -