Reprocessed Baloon Inflation Device
FDA 510(k) K053188 · Sterilmed, Inc.
510(k) numberK053188
Submission
- Device name
- Reprocessed Baloon Inflation Device
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- November 15, 2005
- Decision date
- May 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKU – Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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Questions and answers
When was Reprocessed Baloon Inflation Device cleared by the FDA?
Reprocessed Baloon Inflation Device (K053188) received a 510(k) decision of Substantially Equivalent on May 4, 2006, 170 days after the submission was received.
What is the product code of K053188?
The FDA product code is NKU – Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1650.