CrossBay Cervical Dilator Catheter System— 510(k) K190813

Name: FDA 510(k) clearance K190813
Creator: U.S. Food and Drug Administration
Published: 2019-08-23

Substantially Equivalent

Crossbay Medical

FDA 510(k) clearance K190813 for CrossBay Cervical Dilator Catheter System, Substantially Equivalent on 2019-08-23. Applicant: Crossbay Medical. Device class: 2.

Clearance details

Applicant: Crossbay Medical
Product code: Code PON
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 2019-03-29
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K202433 — Aqueduct 200 Cervical Dilation Balloon Catheter2021-10-15
K202427 — Aqueduct 100 Plus Cervical Dilation Balloon Catheter2020-11-06
K160664 — Aqueduct 100 Cervical Dilator2016-08-01

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