Cleared Traditional

K871080 - PERIPHERALLY INSERTED CENTRAL VENOUS CA...

K871080 is the FDA 510(k) clearance for PERIPHERALLY INSERTED CENTRAL VENOUS CA... by Catheter Technology Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K871080 · Catheter Technology Corp. · Cardiovascular device
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Aug 1987
Decision
147d
Days
Class 2
Risk

K871080 is an FDA 510(k) clearance for the PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Catheter Technology Corp. (Salt Lake City, US). The FDA issued a Cleared decision on August 12, 1987 after a review of 147 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 Catheter Technology Corp. devices

Submission Details

510(k) Number K871080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date August 12, 1987
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
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 591
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K871080.
ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE
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VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
K873035 · Gish Biomedical, Inc. · Sep 1987
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K863791 · Gish Biomedical, Inc. · Jun 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · Gish Biomedical, Inc. · Jun 1987
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K871425 · Advanced Cardiovascular Systems, Inc. · May 1987