FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
K Number: K134019
·
Decision Sep 11, 2014
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
51
Review Days
255
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
- K Number
- K134019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nxstage Medical, Inc.
- Date Received
- December 30, 2013
- Decision Date
- September 11, 2014
- Product Code
- FIE
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS Harmony A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K170469 | NxStage System One Plus | May 9, 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 |