Cleared Traditional

K212719 - Micro Catheter and Guidewire System

K212719 is an FDA 510(k) clearance for Micro Catheter and Guidewire System, manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K212719 · Suzhou Hengrui Hongyuan Medical Co., Ltd. · Cardiovascular device
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Apr 2022
Decision
227d
Days
Class 2
Risk

K212719 is an FDA 510(k) clearance for the Micro Catheter and Guidewire System. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Suzhou Hengrui Hongyuan Medical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on April 11, 2022 after a review of 227 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Suzhou Hengrui Hongyuan Medical Co., Ltd. devices

FDA 510(k) Submission Details - K212719

510(k) Number K212719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2021
Decision Date April 11, 2022
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 125d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 130
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