Cleared Traditional

K872182 - POLYSTAN WIRE REINFORCED CATHETERS AND ...

K872182 is the FDA 510(k) clearance for POLYSTAN WIRE REINFORCED CATHETERS AND ... by Polystan C/O Vitalcor, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K872182 · Polystan C/O Vitalcor, Inc. · Cardiovascular device
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Oct 1987
Decision
144d
Days
Class 2
Risk

K872182 is an FDA 510(k) clearance for the POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Polystan C/O Vitalcor, Inc. (Westmont, US). The FDA issued a Cleared decision on October 30, 1987 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Polystan C/O Vitalcor, Inc. devices

Submission Details

510(k) Number K872182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date October 30, 1987
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 589
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