MARS Monitor ITC US, MARS Treatment Kit Type 1116/1 - X-MARS US, Prismaflex Control Unit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133807 FDA 510(k)
- FDA Product Code
- FLD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5870 FDA 510(k)
- Regulation Number
- 876.5870 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an Apparatus, Hemoperfusion, Sorbent, as defined in the device data. It is indicated for the treatment of drug overdose and poisonings.
The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device for MARS therapy. It received FDA 510(k) clearance under K133807 on March 26, 2014, and is classified as a Class II device with product code FLD.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mars Monitor Itc Us, Mars Treatment Kit Type 1116/1 - X-mars Us ..., Product Catalog - Baxter, AccessGUDID - DEVICE: MARS TREATMENT KIT TYPE 1116/1 - X-MARS US ..., MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133807 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gambro Renal Products, Inc.
Sources (1)
- FDA 510(k) K133807 24 fields · synced Oct 6, 2026