FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NxStage System One Plus
K Number: K170469
·
Decision May 9, 2017
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
51
Review Days
82
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Basic Information
- Device Name
- NxStage System One Plus
- K Number
- K170469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nxstage Medical, Inc.
- Date Received
- February 16, 2017
- Decision Date
- May 9, 2017
- Product Code
- KDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Nxstage Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Mar 14, 2024 | Substantially Equivalent |
| K233213 | NxStage PureFlow Solution | Jan 18, 2024 | Substantially Equivalent |
| K230632 | VersiHD with GuideMe software | Aug 11, 2023 | Substantially Equivalent |
| K183158 | NxStage Cartridge Express with Speedswap | Aug 9, 2019 | Substantially Equivalent |
| K181991 | NxStage Connected Health System | Sep 26, 2018 | Substantially Equivalent |
| K171331 | NxStage System One | Aug 24, 2017 | Substantially Equivalent |
| K150472 | NxStage System One | Jun 4, 2015 | Substantially Equivalent |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | Mar 20, 2015 | Substantially Equivalent |
| K141752 | NXSTAGE SYSTEM ONE | Dec 19, 2014 | Substantially Equivalent |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO | Sep 11, 2014 | Substantially Equivalent |