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510(k) K190813

CrossBay Cervical Dilator Catheter System by Crossbay Medical — Product Code PON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2019
Date Received
March 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Balloon, Dilation Of Cervical Canal
Device Class
Class II
Regulation Number
884.4260
Review Panel
OB
Submission Type

Mechanical dilation and softening of the cervix.

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  • K142545 — SonoFlow Sonohysterography and Sonohysterosalpingography Device (March 20, 2015)
  • K133144 — SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (March 19, 2014)

Other clearances for product code PON

  • K202433 — Aqueduct 200 Cervical Dilation Balloon Catheter (October 15, 2021)
  • K202427 — Aqueduct 100 Plus Cervical Dilation Balloon Catheter (November 6, 2020)
  • K160664 — Aqueduct 100 Cervical Dilator (August 1, 2016)