FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER
K Number: K881695
·
Decision Jun 23, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
20
Review Days
65
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
- DESERET SUBCLAVIAN HEMODIALYSIS CATHETER
- K Number
- K881695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Deseret Medical, Inc.
- Date Received
- April 19, 1988
- Decision Date
- June 23, 1988
- 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 Deseret Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913027 | VESSEL DILATOR | Nov 27, 1991 | Substantially Equivalent |
| K904648 | SAFE SYTE I.V. CATHETER PLACEMENT UNIT | Dec 14, 1990 | Substantially Equivalent |
| K904121 | VIALON OBTURATOR | Nov 8, 1990 | Substantially Equivalent |
| K904122 | INSYTE-A ARTERIAL CATHETERIZATION UNIT | Oct 4, 1990 | Substantially Equivalent |
| K900116 | DESERET OPTIMA INTRAVASCULAR CATHETER | Jun 18, 1990 | Substantially Equivalent |
| K895735 | DESERET MULTILUMEN SUBCLAVIAN CATHETER | May 18, 1990 | Substantially Equivalent |
| K895734 | DESERET INTRAVASCULAR CATHETER | Apr 9, 1990 | Substantially Equivalent |
| K894033 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | Oct 17, 1989 | Substantially Equivalent |
| K893406 | DESERET PRN ADAPTER | Jun 22, 1989 | Substantially Equivalent |
| K882797 | LUER-LOK MULTIFLO ADAPTER | Jul 18, 1988 | Substantially Equivalent |