FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMER. BENTLEY HEMOFILTER HOLDER HFH-1
K Number: K843504
·
Decision Oct 18, 1984
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
59
Review Days
42
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Basic Information
- Device Name
- AMER. BENTLEY HEMOFILTER HOLDER HFH-1
- K Number
- K843504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Bentley
- Date Received
- September 6, 1984
- Decision Date
- October 18, 1984
- Product Code
- FKI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKI | Set, Dialyzer Holder | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKI), ordered by most recent decision date.
PARALLEL PLATE DIALYZER HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOLLOW FIBER DIALYZER HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by American Bentley
| K Number | Device Name | ||
|---|---|---|---|
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | Feb 12, 1988 | Substantially Equivalent |
| K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Nov 6, 1987 | Substantially Equivalent |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | Sep 1, 1987 | Substantially Equivalent |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | Sep 1, 1987 | Substantially Equivalent |
| K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS | Aug 24, 1987 | Substantially Equivalent |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | May 29, 1987 | Substantially Equivalent |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | Mar 9, 1987 | Substantially Equivalent |
| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | Oct 20, 1986 | Substantially Equivalent |
| K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS | Sep 29, 1986 | Substantially Equivalent |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | Jul 15, 1986 | Substantially Equivalent |