NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory— 510(k) K143678
UnknownNinepoint Medical, Inc.
FDA 510(k) clearance K143678 for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory, Unknown on 2015-02-06. Applicant: Ninepoint Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ninepoint Medical, Inc.
- Product code
- Code NQQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Cambridge, MA, US
Recent devices under product code NQQ
view allMore clearances from Ninepoint Medical, Inc.
view all- K191117 — NvisionVLE Low-profile Optical Probe
- K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K153479 — NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
- K120800 — NVISION VLE IMAGING SYSTEM
Recalls naming K143678
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143678.
Data sourced from openFDA. This site is unofficial and independent of the FDA.