AIRCAST VENAFLOW ELITE SYSTEM
FDA 510(k) clearance K130722 · decided 2013-06-20
Clearance details
- K-number
- K130722
- Device name
- AIRCAST VENAFLOW ELITE SYSTEM
- Applicant
- Djo, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-03-18
- Decision date
- 2013-06-20
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Djo
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic) (P910066/S031) | Djo, LLC | 2020-01-23 |
| Bone Growth Stimulators (P910066/S030) | Djo, LLC | 2019-08-02 |
| OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators (P910066/S029) | Djo, LLC | 2018-06-19 |
| OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S028) | Djo, LLC | 2016-02-18 |
| OL1000, OL1000 SC, SPINALOGIC (P910066/S027) | Djo, LLC | 2015-07-24 |
| OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S026) | Djo, LLC | 2012-08-10 |
| SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS (P910066/S025) | Djo, LLC | 2008-12-24 |
| OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE (P910066/S024) | Djo, LLC | 2007-12-10 |