STERILEMED REPROCESSED IVUS IMAGING CATHETER— 510(k) K043453
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K043453 for STERILEMED REPROCESSED IVUS IMAGING CATHETER, Substantially Equivalent on 2005-03-01. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
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Recalls naming K043453
K-number listed on FDA's recall record- Z-0573-2026 — Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
- Z-0574-2026 — Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043453.
Data sourced from openFDA. This site is unofficial and independent of the FDA.