ANGIOMED INTRODUCING SETS— 510(k) K874771
Substantially EquivalentAngiomed U.S., Inc.
FDA 510(k) clearance K874771 for ANGIOMED INTRODUCING SETS, Substantially Equivalent on 1988-01-12. Applicant: Angiomed U.S., Inc.. Device class: 2.
Clearance details
- Applicant
- Angiomed U.S., Inc.
- Product code
- Code DWB
- Device class
- Class 2
- Regulation
- 21 CFR 870.4370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code DWB
view all- K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
- K131618 — LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
- K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
- K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM
- K972321 — S3 MAST PUMP
More clearances from Angiomed U.S., Inc.
view allAdverse events under product code DWB
product code DWB- Death
- 2
- Total
- 2
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.