Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters— 510(k) K981660
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K981660 for Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters, Substantially Equivalent on 1998-10-16. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code DSP
- Device class
- Class 2
- Regulation
- 21 CFR 870.3535
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haverhill, MA, US
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Adverse events under product code DSP
product code DSP- Death
- 317
- Injury
- 566
- Malfunction
- 36,831
- Other
- 4
- Total
- 37,718
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 K981660
K-number listed on FDA's recall record- Z-1061-2016 — RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
- Z-1063-2016 — Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981660.
Data sourced from openFDA. This site is unofficial and independent of the FDA.