MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.— 510(k) K891611
Substantially EquivalentMedtronic Versaflex, Inc.
FDA 510(k) clearance K891611 for MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH., Substantially Equivalent on 1989-06-12. Applicant: Medtronic Versaflex, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Versaflex, Inc.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
More clearances from Medtronic Versaflex, Inc.
view allAdverse events under product code LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.