510(k) K062429
- Device
- MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
- Applicant
- EDWARDS LIFESCIENCES RESEARCH MEDICAL
- 510(k) number
- K062429
- Product code
- DTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-09-27
- Date received
- 2006-08-21
- Regulation
- 870.4260
- Classification name
- Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN JONES
- Address
- 6864 S. 300 W. Midvale UT US 84047 84047
FDA Registration Numbers#
- 9617601
- 3031571797
- 3003152463
- 2029275
- 9681834
- 3008307705
- 3002806603
- 1625519
- 3011554160
- 3003752502
- 2184009
- 3008132398
- 1724474
- 3008500478
- 1643817
- 3005941719
- 2011171
- 1124841
- 1319639
- 9680841
- 8010026
- 1928237
- 3005012805
- 3002807090
- 8010762
Source Documents#
Other 510(k) Records For Product Code DTM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251744 | Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic | 2026-01-16 |
| K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | 2024-12-20 |
| K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | 2024-11-18 |
| K231362 | OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. | 2023-10-31 |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | Medtronic Perfusion Systems | 2013-03-19 |
| K122760 | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2012-12-07 |
| K121209 | TERUMO PALL AL20X ARTERIAL FILTER | Terumo Cardiovascular Systems Corporation | 2012-05-08 |
| K112525 | D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS | Parexel International | 2011-09-29 |
| K100646 | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2010-12-16 |
| K093986 | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS | Sorin Group Italia S.R.L. | 2010-01-22 |
| K093601 | AF 840 PH.I.S.I.O. ARTERIAL FILTER | Sorin Group Italia S.R.L. | 2009-12-18 |
| K090518 | QUART ARTERIAL FILTER WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-18 |
| K083747 | TERUMO PALL AL3X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2009-08-20 |
| K083834 | TERUMO PALL AL6X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2009-04-17 |
| K081054 | GISH ARTERIAL FILTER WITH HA COATING | Gish Biomedical, Inc. | 2009-01-15 |
Legacy Summary#
summary