Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh
FDA 510(k) K062429 · Edwards Lifesciences Research Medical
510(k) numberK062429
Submission
- Device name
- Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh
- Applicant
- Edwards Lifesciences Research Medical
Midvale, UT, US - Received
- August 21, 2006
- Decision date
- September 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4260
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K121209 | Terumo Pall AL20X Arterial FilterDTM · Special | Terumo Cardiovascular Systems Corporation | 05/08/2012SE |
| K112525 | D731 Micro 27 Ph.I.S.I.O. and D733 Micro 40 Ph.I.S.O. Arterial FiltersDTM · Special | Parexel International | 09/29/2011SE |
| K100646 | Affinity Pixie Arterial Filter with Balance BiosurfaceDTM · Traditional | Medtronic, Inc. | 12/16/2010SE |
| K093986 | Af 620 Ph.I.S.I.O., Af 640 Ph.I.S.I.O. Arterial FiltersDTM · Special | Sorin Group Italia S.R.L. | 01/22/2010SE |
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| K991170 | Retrograde Cardioplegia Cannula with Duraflo Treatment, Model DII-RC-014DWF · Traditional | 07/02/1999SE |
| K983791 | Peripheral Retrograde Cardiaplegia CannulaDWF · Traditional | 06/11/1999SE |
| K974259 | Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeDWF · Traditional | 12/01/1998SE |
Questions and answers
When was Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh cleared by the FDA?
Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh (K062429) received a 510(k) decision of Substantially Equivalent on September 27, 2006, 37 days after the submission was received.
What is the product code of K062429?
The FDA product code is DTM – Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a Class II (moderate risk) device regulated under 21 CFR 870.4260.