Nanocorss .014 Otw Pta Dilatation Catheter
FDA 510(k) K082854 · Ev3, Inc.
510(k) numberK082854
Submission
- Device name
- Nanocorss .014 Otw Pta Dilatation Catheter
- Applicant
- Ev3, Inc.
Plymouth, MN, US - Received
- September 29, 2008
- Decision date
- December 4, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
|---|---|---|
| K141118 | Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation CatheterLIT · Special | 07/18/2014SE |
| K132777 | Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation CatheterLIT · Traditional | 09/26/2013SE |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterLIT · Traditional | 05/24/2013SE |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterLIT · Traditional | 02/12/2013SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | 09/16/2011SE |
| K110319 | Evercross 0.035 Otw Pta Dilatation CatheterLIT · Special | 04/14/2011SE |
| K103618 | Turbohawk Peropheral Plaque Excision SystemMCW · Traditional | 01/05/2011SE |
| K103322 | Evercross 0.035 Otw Pta Dilation CatheterLIT · Traditional | 12/06/2010SE |
Questions and answers
When was Nanocorss .014 Otw Pta Dilatation Catheter cleared by the FDA?
Nanocorss .014 Otw Pta Dilatation Catheter (K082854) received a 510(k) decision of Substantially Equivalent on December 4, 2008, 66 days after the submission was received.
What is the product code of K082854?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.