Bard Intra-Abdominal Pressure Monitoring Device, Model IAP-001
FDA 510(k) K070201 · C.R. Bard, Inc.
510(k) numberK070201
Submission
- Device name
- Bard Intra-Abdominal Pressure Monitoring Device, Model IAP-001
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- January 22, 2007
- Decision date
- August 1, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHU – Intra-Abdominal Pressure Monitoring Device
- Device class
- Unclassified
- Implant
- Yes
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Other 510(k)s with product code PHU
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|---|---|---|---|
| K210570 | TraumaGuard Intra-abdominal Pressure Sensing SystemPHU · Traditional | Sentinel Medical Technologies, LLC | 10/29/2021SE |
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Questions and answers
When was Bard Intra-Abdominal Pressure Monitoring Device, Model IAP-001 cleared by the FDA?
Bard Intra-Abdominal Pressure Monitoring Device, Model IAP-001 (K070201) received a 510(k) decision of Substantially Equivalent on August 1, 2007, 191 days after the submission was received.
What is the product code of K070201?
The FDA product code is PHU – Intra-Abdominal Pressure Monitoring Device, a Unclassified device.