FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
K Number: K133157
·
Decision Oct 23, 2014
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
209
Review Days
371
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
- K Number
- K133157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- October 17, 2013
- Decision Date
- October 23, 2014
- Product Code
- DRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRY), ordered by most recent decision date.
CDI OneView Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
B-Capta
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Workstation 12 Elite
FDA 510(k)
FDA Class 2
·Cardiovascular
CDI Blood Parameter Monitoring System 550
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Workstation 12.1
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medtronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Apr 23, 2026 | Substantially Equivalent |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Feb 19, 2026 | Substantially Equivalent |
| K253998 | Clearview Intracoronary Shunts | Jan 20, 2026 | Substantially Equivalent |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | Jan 15, 2026 | Substantially Equivalent |
| K253511 | Concerto Versa Detachable Coil | Jan 14, 2026 | Substantially Equivalent |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Dec 19, 2025 | Substantially Equivalent |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Jun 20, 2025 | Substantially Equivalent |
| K250075 | Medtronic Stedi Extra Support Guidewire | Jun 13, 2025 | Substantially Equivalent |
| K250199 | VitalFlow Console | May 20, 2025 | Substantially Equivalent |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Mar 27, 2025 | Substantially Equivalent |