FOGARTY ARTERIAL EMBOLECTOMY II CATHETER— 510(k) K901625
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K901625 for FOGARTY ARTERIAL EMBOLECTOMY II CATHETER, Substantially Equivalent on 1990-07-06. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DXE
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DXE
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Adverse events under product code DXE
product code DXE- Death
- 27
- Injury
- 258
- Malfunction
- 2,266
- Total
- 2,551
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 K901625
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K901625.
Data sourced from openFDA. This site is unofficial and independent of the FDA.