Nxstage Travel Warmer, Models TW-400 & FWS-500
FDA 510(k) K071263 · Nxstage Medical, Inc.
510(k) numberK071263
Submission
- Device name
- Nxstage Travel Warmer, Models TW-400 & FWS-500
- Applicant
- Nxstage Medical, Inc.
Lawrence, MA, US - Received
- May 7, 2007
- Decision date
- August 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K170469 | NxStage System One PlusKDI · Traditional | 05/09/2017SE |
| K150472 | NxStage System OneODN · Special | 06/04/2015SE |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) CartridgeKDI · Traditional | 03/20/2015SE |
| K141752 | Nxstage System OneODN · Traditional | 12/19/2014SE |
Questions and answers
When was Nxstage Travel Warmer, Models TW-400 & FWS-500 cleared by the FDA?
Nxstage Travel Warmer, Models TW-400 & FWS-500 (K071263) received a 510(k) decision of Substantially Equivalent on August 24, 2007, 109 days after the submission was received.
What is the product code of K071263?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.