Cleared Traditional

K170958 - ChitoPulse 9in / 23 cm

K170958 is an FDA 510(k) clearance for ChitoPulse 9in / 23 cm, manufactured by Tricol Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K170958 · Tricol Biomedical, Inc. · Cardiovascular device
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Aug 2017
Decision
151d
Days
Class 2
Risk

K170958 is an FDA 510(k) clearance for the ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Tricol Biomedical, Inc. (Portland, US). The FDA issued a Cleared decision on August 29, 2017 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Tricol Biomedical, Inc. devices

FDA 510(k) Submission Details - K170958

510(k) Number K170958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date August 29, 2017
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K170958.
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IntraClude Intra-Aortic Occlusion Device
K163693 · Edwards Lifesciences, LLC · Jan 2017
PreludeSYNC Radial Compression Device
K162988 · Merit Medical Systems, Inc. · Jan 2017
TRAcelet Compression Device
K162027 · Medtronic Vascular · Oct 2016