Cleared Traditional

Micro Catheter and Guidewire System (K212719) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 73
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