Mini Ghost, Model: 507
FDA 510(k) K082524 · NuMED, Inc.
510(k) numberK082524
Submission
- Device name
- Mini Ghost, Model: 507
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- September 2, 2008
- Decision date
- September 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Mini Ghost, Model: 507 cleared by the FDA?
Mini Ghost, Model: 507 (K082524) received a 510(k) decision of Substantially Equivalent on September 26, 2008, 24 days after the submission was received.
What is the product code of K082524?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.