FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORAY ANTHRON ANGIOGRAPHIC CATHETERS
K Number: K872983
·
Decision Nov 20, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
24
Applicant Total
18
Review Days
112
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
- TORAY ANTHRON ANGIOGRAPHIC CATHETERS
- K Number
- K872983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Toray Industries (America), Inc.
- Date Received
- July 31, 1987
- Decision Date
- November 20, 1987
- Product Code
- DQR
- 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 |
|---|---|---|---|
| DQR | Cannula, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQR), ordered by most recent decision date.
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
FDA 510(k)
FDA Class 2
·Cardiovascular
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIODYNAMICS, INC., MICRO ACCESS KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
FDA 510(k)
FDA Class 2
·Cardiovascular
RMI INTERNAL MAMMARY ARTERY CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Toray Industries (America), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042370 | TORAYGUIDE GUIDEWIRE | Dec 17, 2004 | Substantially Equivalent |
| K030050 | TORAYSULFONE DIALYZER, BS-L SERIES | Sep 29, 2003 | Substantially Equivalent |
| K002512 | TORAYSULFONE DIALYZER | Oct 15, 2001 | Substantially Equivalent |
| K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L | Aug 25, 2000 | Substantially Equivalent |
| K942681 | FILTRYZER | Jun 22, 1995 | Substantially Equivalent |
| K935471 | FILTRYZER(TM) | May 19, 1995 | Substantially Equivalent |
| K940910 | FILTRYZER | May 4, 1995 | Substantially Equivalent |
| K884339 | TORAY FILTRYZER DIALYZERS | Mar 17, 1989 | Substantially Equivalent |
| K883407 | TORAY FILTRYZER BK SERIES | Feb 27, 1989 | Substantially Equivalent |
| K884083 | TORAY VASCULAR PROSTHESIS | Jan 12, 1989 | Substantially Equivalent |