STERILEMED REPROCESSED IVUS IMAGING CATHETER
FDA 510(k) clearance K043453 · decided 2005-03-01
Clearance details
- K-number
- K043453
- Device name
- STERILEMED REPROCESSED IVUS IMAGING CATHETER
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-15
- Decision date
- 2005-03-01
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- OWQ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYS recall (Z-0573-2026) | Sterilmed, Inc. | 2025-11-20 |
| Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV D recall (Z-0574-2026) | Sterilmed, Inc. | 2025-11-20 |
| Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular or recall (Z-0551-2009) | Sterilmed Inc | 2009-01-13 |