FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOPPLER MONITOR
K Number: K110347
·
Decision Mar 16, 2011
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
12
Review Days
37
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
- DOPPLER MONITOR
- K Number
- K110347
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Vascular, Inc.
- Date Received
- February 7, 2011
- Decision Date
- March 16, 2011
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Cook Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | Nov 12, 2014 | Substantially Equivalent |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | Jul 1, 2014 | Substantially Equivalent |
| K083482 | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET | Apr 2, 2009 | Substantially Equivalent |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | Sep 30, 2008 | Substantially Equivalent |
| K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 | May 10, 2006 | Substantially Equivalent |
| K032223 | COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH | Oct 15, 2003 | Substantially Equivalent |
| K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM | May 27, 2003 | Substantially Equivalent |
| K022649 | COOK-SWARTZ DOPPLER FLOW PROBE | Sep 6, 2002 | Substantially Equivalent |
| K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | Apr 25, 2002 | Substantially Equivalent |
| K002958 | SHAPEABLE DOPPLER FLOW PROBE | Dec 18, 2001 | Substantially Equivalent |