FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOGARTY OCCLUSION CATHETER
K Number: K093911
·
Decision Jan 21, 2010
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
136
Review Days
30
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
- FOGARTY OCCLUSION CATHETER
- K Number
- K093911
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- December 22, 2009
- Decision Date
- January 21, 2010
- Product Code
- MJN
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MJN), ordered by most recent decision date.
pREBOA-PRO Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Bridge Plus Occlusion Balloon (590-002)
FDA 510(k)
FDA Class 2
·Cardiovascular
preCARDIA Occlusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
LANDMARK REBOA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Occlusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
RenovoCath
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Edwards Lifesciences, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K251326 | Respiration Rate algorithm | Jun 11, 2026 | Substantially Equivalent |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Feb 24, 2026 | Substantially Equivalent |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Sep 23, 2025 | Substantially Equivalent |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Sep 17, 2025 | Substantially Equivalent |
| K242518 | Hypertension Prediction Index (HePI) Algorithm | May 15, 2025 | Substantially Equivalent |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Mar 21, 2025 | Substantially Equivalent |
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Aug 28, 2024 | Substantially Equivalent |
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Aug 2, 2024 | Substantially Equivalent |
| K233824 | Swan-Ganz catheter | Jun 6, 2024 | Substantially Equivalent |
| K233819 | Fogarty Venous Thrombectomy Catheters | May 22, 2024 | Substantially Equivalent |