CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM— 510(k) K980487
Substantially EquivalentBaxter Edwards
FDA 510(k) clearance K980487 for CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM, Substantially Equivalent on 1998-07-07. Applicant: Baxter Edwards. Device class: 2.
Clearance details
- Applicant
- Baxter Edwards
- Product code
- Code KRH
- Device class
- Class 2
- Regulation
- 21 CFR 870.3800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code KRH
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- K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS
- K965137 — FOGARTY VALVULOTOME MODEL 700091
- K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
- K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
Adverse events under product code KRH
product code KRH- Death
- 45
- Injury
- 2,235
- Total
- 2,280
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.