Cleared Traditional

K190475 - Delivery Catheter SSPC1

K190475 is an FDA 510(k) clearance for Delivery Catheter SSPC1, manufactured by Centerpoint Systems. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K190475 · Centerpoint Systems · Cardiovascular device
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Jun 2019
Decision
121d
Days
Class 2
Risk

K190475 is an FDA 510(k) clearance for the Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, De.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Centerpoint Systems (West Valley City, US). The FDA issued a Cleared decision on June 28, 2019 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Centerpoint Systems devices

FDA 510(k) Submission Details - K190475

510(k) Number K190475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2019
Decision Date June 28, 2019
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K190475.
CerusEndo Microcatheter
K182487 · Cerus Endovascular, Inc. · Jul 2019
087 Balloon Guide Catheter System
K190749 · Q'Apel · Jul 2019
Scepter Mini Occlusion Balloon Catheter
K182829 · MicroVention, Inc. · Jul 2019
ASAHI SASUKE
K182844 · Asahi Intecc Co., Ltd. · Jun 2019
Upstream GoBack Crossing Catheter
K182937 · Upstream Peripheral Technologies, Ltd. · May 2019
SOFIA EX Intracranial Support Catheter
K182602 · MicroVention, Inc. · May 2019