Cleared Traditional

K152202 - Intermediate Catheter

K152202 is an FDA 510(k) clearance for Intermediate Catheter, manufactured by Tni Manufacturing, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K152202 · Tni Manufacturing, Inc. · Cardiovascular device
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Dec 2015
Decision
130d
Days
Class 2
Risk

K152202 is an FDA 510(k) clearance for the Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Cat.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Tni Manufacturing, Inc. (Sunrise, US). The FDA issued a Cleared decision on December 14, 2015 after a review of 130 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 Tni Manufacturing, Inc. devices

FDA 510(k) Submission Details - K152202

510(k) Number K152202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2015
Decision Date December 14, 2015
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQY Device Classification - Class 2, Special Controls

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 651
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K152202.
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AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
K151667 · Stryker · Nov 2015