Cleared Traditional

K193647 - Superpipe Angiographic Catheter

K193647 is the FDA 510(k) clearance for Superpipe Angiographic Catheter by Suzhou Hengrui Disheng Medical Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K193647 · Suzhou Hengrui Disheng Medical Co., Ltd. · Cardiovascular device
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Jul 2020
Decision
212d
Days
Class 2
Risk

K193647 is an FDA 510(k) clearance for the Superpipe Angiographic Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Suzhou Hengrui Disheng Medical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 29, 2020 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Disheng Medical Co., Ltd. devices

Submission Details

510(k) Number K193647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date July 29, 2020
Days to Decision 212 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
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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.

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All 291
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