INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
FDA 510(k) clearance K090584 · decided 2009-11-24
Clearance details
- K-number
- K090584
- Device name
- INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
- Applicant
- Carl Zeiss Surgical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-03-03
- Decision date
- 2009-11-24
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRA recall (Z-0404-2013) | Carl Zeiss Meditec, Inc. | 2012-11-20 |
| INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRA recall (Z-0405-2013) | Carl Zeiss Meditec, Inc. | 2012-11-20 |
| INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRA recall (Z-0406-2013) | Carl Zeiss Meditec, Inc. | 2012-11-20 |
| INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Car recall (Z-2989-2011) | Carl Zeiss Meditec, Inc. | 2011-08-10 |