FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HE-30 GOLD
K Number: K931967
·
Decision Jul 13, 1993
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
90
Applicant Total
55
Review Days
83
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Basic Information
- Device Name
- HE-30 GOLD
- K Number
- K931967
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bentley Laboratories, Inc.
- Date Received
- April 21, 1993
- Decision Date
- July 13, 1993
- Product Code
- DTR
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Bentley Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | Jan 17, 1992 | Substantially Equivalent |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | Nov 15, 1991 | Substantially Equivalent |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | Nov 9, 1990 | Substantially Equivalent |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | Feb 28, 1990 | Substantially Equivalent |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Feb 2, 1988 | Substantially Equivalent |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Jan 5, 1983 | Substantially Equivalent |
| K823456 | OXYGENATORS #BOS-10, 105, 5S | Dec 30, 1982 | Substantially Equivalent |