510(k) K053188
K053188 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED BALOON INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on May 4, 2006. The device falls under product code NKU (Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed), a Class II device regulated under 21 CFR 870.1650. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2006
- Date Received
- November 15, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- CV
- Submission Type