FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
K Number: K033793
·
Decision Dec 16, 2003
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
13
Review Days
11
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
- CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
- K Number
- K033793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rex Medical
- Date Received
- December 5, 2003
- Decision Date
- December 16, 2003
- Product Code
- MCW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCW), ordered by most recent decision date.
Auryon Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
FDA 510(k)
FDA Class 2
·Cardiovascular
Turbo-Elite Laser Atherectomy Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Rotarex Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
FreedomFlow Orbital Circumferential Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Rex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Jun 1, 2012 | Substantially Equivalent |
| K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | May 22, 2012 | Substantially Equivalent |
| K102043 | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER | Nov 18, 2010 | Substantially Equivalent |
| K091029 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) | Feb 18, 2010 | Substantially Equivalent |
| K081410 | OPTION VENA CAVA FILTER | Jun 4, 2009 | Substantially Equivalent |
| K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET | Aug 22, 2007 | Unknown |
| K051468 | INNER-LOCK INTRODUCER SHEATH | Aug 4, 2005 | Substantially Equivalent |
| K040252 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT | Feb 26, 2004 | Substantially Equivalent |
| K032569 | SHORT INTRODUCER SHEATH | Sep 16, 2003 | Substantially Equivalent |
| K031610 | REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM | May 27, 2003 | Substantially Equivalent |