FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
K Number: K122178
·
Decision Oct 11, 2012
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
85
Applicant Total
12
Review Days
80
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Basic Information
- Device Name
- FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
- K Number
- K122178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ostial Corporation
- Date Received
- July 23, 2012
- Decision Date
- October 11, 2012
- Product Code
- LOX
- 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 |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Ostial Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm | Feb 16, 2016 | Substantially Equivalent |
| K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm | May 8, 2015 | Substantially Equivalent |
| K133861 | FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM | Jul 2, 2014 | Substantially Equivalent |
| K131450 | FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 | Aug 6, 2013 | Substantially Equivalent |
| K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM | Sep 5, 2012 | Substantially Equivalent |
| K121175 | FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM | Jun 29, 2012 | Substantially Equivalent |
| K113582 | ARCHSTENT BILIARY SYSTEM | Jun 29, 2012 | Unknown |
| K113775 | FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM | Jun 29, 2012 | Substantially Equivalent |
| K120738 | FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM | Mar 29, 2012 | Substantially Equivalent |
| K111284 | FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM | Aug 17, 2011 | Substantially Equivalent |