FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000
K Number: K994141
·
Decision Jul 21, 2000
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
13
Review Days
226
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
- CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000
- K Number
- K994141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Ave, Inc.
- Date Received
- December 8, 1999
- Decision Date
- July 21, 2000
- 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 Medtronic Ave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032768 | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) | Oct 9, 2003 | Unknown |
| K030633 | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT | Sep 2, 2003 | Unknown |
| K030839 | MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) | May 30, 2003 | Unknown |
| K022026 | MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) | Jul 19, 2002 | Unknown |
| K014205 | MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) | Jan 14, 2002 | Unknown |
| K011080 | BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM | Oct 11, 2001 | Unknown |
| K011817 | BRIDGE FX | Aug 22, 2001 | Unknown |
| K002346 | WIRE, GUIDE, CATHETER, MODEL QSW1000 | Sep 27, 2000 | Substantially Equivalent |
| K000744 | MEDTRONIC AVE BRIDGE X3 STENT | Jun 5, 2000 | Unknown |
| K993145 | MEDTRONIC AVE BRIDGE STENT | Oct 21, 1999 | Unknown |