FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBE ACUFLEX SSN, #15-220
K Number: K820238
·
Decision Mar 10, 1982
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
77
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
- COBE ACUFLEX SSN, #15-220
- K Number
- K820238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cobe Laboratories, Inc.
- Date Received
- January 28, 1982
- Decision Date
- March 10, 1982
- Product Code
- LFJ
- 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 |
|---|---|---|---|
| LFJ | Catheter, Subclavian | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFJ), ordered by most recent decision date.
MEDSURG INSERTION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AKCESS0CATH KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AKCESS-CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPLITTABLE SHEATH INTRODUCER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COAXIAL ACUTE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cobe Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | May 11, 1993 | Substantially Equivalent |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | Mar 22, 1991 | Substantially Equivalent |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | Feb 12, 1991 | Substantially Equivalent |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | Feb 11, 1991 | Substantially Equivalent |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Dec 27, 1990 | Substantially Equivalent |
| K902631 | COBE ICU CONVERSION KIT | Dec 17, 1990 | Substantially Equivalent |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Dec 17, 1990 | Substantially Equivalent |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | Dec 12, 1990 | Substantially Equivalent |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | Aug 23, 1990 | Substantially Equivalent |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | Jul 18, 1990 | Substantially Equivalent |