510(k) K093992
K093992 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "TERUMO LAUER LOCK ADAPTER". The FDA issued a decision of Substantially Equivalent on May 19, 2010. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2010
- Date Received
- December 24, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4290
- Review Panel
- CV
- Submission Type