IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM— 510(k) K961924
Substantially EquivalentIrvine Biomedical, Inc.
FDA 510(k) clearance K961924 for IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM, Substantially Equivalent on 1997-04-11. Applicant: Irvine Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Irvine Biomedical, Inc.
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DRF
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- K060757 — INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
- K053582 — INQUIRY AFOCUS II DIAGNOSTIC CATHETER
- K042775 — INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
- K010471 — AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
Adverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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 →
Recalls naming K961924
K-number listed on FDA's recall record- Z-3011-2020 — Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
- Z-3012-2020 — Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961924.
Data sourced from openFDA. This site is unofficial and independent of the FDA.