FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOLDER FOR BOS-10, 10S 5S
K Number: K841812
·
Decision Jun 11, 1984
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
41
Applicant Total
59
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HOLDER FOR BOS-10, 10S 5S
- K Number
- K841812
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Bentley
- Date Received
- May 1, 1984
- Decision Date
- June 11, 1984
- Product Code
- KRI
- 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 |
|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRI), ordered by most recent decision date.
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
FDA 510(k)
FDA Class 1
·Cardiovascular
INTERFACE MODULE IDDD
FDA 510(k)
FDA Class 1
·Cardiovascular
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
FDA 510(k)
FDA Class 1
·Cardiovascular
AMMEX TUBING ORGANIZER
FDA 510(k)
FDA Class 1
·Cardiovascular
CARDIO2 CYCLE
FDA 510(k)
FDA Class 1
·Cardiovascular
TUBE GRIP
FDA 510(k)
FDA Class 1
·Cardiovascular
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 |