510(k) K981441
K981441 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "HEART CATH TRAY, STERILE, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on July 10, 1998. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1998
- Date Received
- April 21, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type