Cleared Traditional

K193647 - Superpipe Angiographic Catheter

K193647 is an FDA 510(k) clearance for Superpipe Angiographic Catheter, manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. The device is a Class 2 Cardiovascular device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K193647

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.

DQO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K193647.
Progreat Lambda
K211078 · Terumo Clinical Supply Co., Ltd. · Dec 2021
Drakon and Sequre Microcatheters
K203487 · Accurate Medical Therapeutics, Ltd. · Dec 2020
Drakon and Sequre Microcatheters
K202797 · Accurate Medical Therapeutics, Ltd. · Oct 2020
ILUMIEN System with AptiVue Software version D.3
K192267 · Abbott Medical · Dec 2019
Trevo Trak 21 Microcatheter
K192122 · Stryker · Nov 2019
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019 · Abbott Medical · Nov 2019