TraumaGuard Intra-abdominal Pressure Sensing System
FDA 510(k) clearance K210570 · decided 2021-10-29
Clearance details
- K-number
- K210570
- Device name
- TraumaGuard Intra-abdominal Pressure Sensing System
- Applicant
- Sentinel Medical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-02-26
- Decision date
- 2021-10-29
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- PHU
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Jacksonville, FL, 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 |
|---|---|---|
| BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (K070201) | C.R. Bard, Inc. | 2007-08-01 |
Recalls involving this device
No recalls on record reference this clearance.