CrossBay Cervical Dilator Catheter System
FDA 510(k) clearance K190813 · decided 2019-08-23
Clearance details
- K-number
- K190813
- Device name
- CrossBay Cervical Dilator Catheter System
- Applicant
- Crossbay Medical
- Decision
- Substantially Equivalent
- Date received
- 2019-03-29
- Decision date
- 2019-08-23
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- PON
- Device class
- 2
- Regulation number
- 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) | Gtimd, LLC | 2021-10-15 |
| Aqueduct 100 Plus Cervical Dilation Balloon Catheter (K202427) | Gtimd, LLC | 2020-11-06 |
| Aqueduct 100 Cervical Dilator (K160664) | Gtimd, LLC | 2016-08-01 |
Recalls involving this device
No recalls on record reference this clearance.