BLOOD CARDIOPLEGIA STAINLESS STEEL COOL— 510(k) K831157
Substantially EquivalentAmerican Bentley
FDA 510(k) clearance K831157 for BLOOD CARDIOPLEGIA STAINLESS STEEL COOL, Substantially Equivalent on 1983-05-09. Applicant: American Bentley. Device class: 2.
Clearance details
- Applicant
- American Bentley
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DTR
view all- K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K250150 — VANGUARD Blood cardioplegia Systems (3 models)
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
More clearances from American Bentley
view allAdverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
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.