MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
FDA 510(k) clearance K072486 · decided 2008-08-06
Clearance details
- K-number
- K072486
- Device name
- MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
- Applicant
- Hem Con Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-04
- Decision date
- 2008-08-06
- Days to decision
- 337 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). L recall (Z-1493-2012) | Siemens Medical Solutions USA, Inc | 2012-05-07 |
| ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT recall (Z-2789-2011) | Siemens Medical Solutions USA, Inc | 2011-07-11 |
| ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). L recall (Z-2404-2011) | Siemens Medical Solutions USA, Inc | 2011-06-02 |
| ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 syste recall (Z-2243-2011) | Siemens Medical Solutions USA, Inc | 2011-05-23 |
| ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combi recall (Z-2216-2011) | Siemens Medical Solutions USA, Inc | 2011-05-19 |
| ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize recall (Z-2190-2011) | Siemens Medical Solutions USA, Inc | 2011-05-12 |