ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
FDA 510(k) clearance K112456 · decided 2011-10-04
Clearance details
- K-number
- K112456
- Device name
- ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-25
- Decision date
- 2011-10-04
- Days to decision
- 40 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Teleflexmedical
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
| Record | Firm | Date |
|---|---|---|
| 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 4 recall (Z-1328-2014) | Teleflex Medical | 2014-04-02 |
| 5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usag recall (Z-1286-2014) | Teleflex Medical | 2014-03-25 |
| 5/10 Weck Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: recall (Z-1287-2014) | Teleflex Medical | 2014-03-25 |
| 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage: An recall (Z-1288-2014) | Teleflex Medical | 2014-03-25 |
| 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usa recall (Z-1289-2014) | Teleflex Medical | 2014-03-25 |
| 5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm), Product Usage: recall (Z-1290-2014) | Teleflex Medical | 2014-03-25 |