Cleared Traditional

Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4

K190475 · Centerpoint Systems · Cardiovascular

Jun 2019

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K190475 is an FDA 510(k) clearance for the Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Centerpoint Systems (West Valley City, US). The FDA issued a Cleared decision on June 28, 2019, 121 days after receiving the submission on February 27, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K190475 FDA.gov
FDA Decision	Cleared 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