CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING— 510(k) K993189
Substantially EquivalentTerumo Corp.
FDA 510(k) clearance K993189 for CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING, Substantially Equivalent on 2000-03-01. Applicant: Terumo Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Corp.
- Product code
- Code DWE
- Device class
- Class 2
- Regulation
- 21 CFR 870.4390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkton, MD, US
Recent devices under product code DWE
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view all- K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
- K092372 — HEARTRAIL III GUIDING CATHETER
- K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
- K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
- K073474 — CAPIOX CIRCUIT CONNECTORS
Adverse events under product code DWE
product code DWE- Death
- 9
- Malfunction
- 754
- Total
- 763
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.