FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC INTRASCULAR CATHETER
K Number: K903848
·
Decision Mar 25, 1991
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
21
Review Days
216
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
- DIAGNOSTIC INTRASCULAR CATHETER
- K Number
- K903848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Vascular Devices, Inc.
- Date Received
- August 21, 1990
- Decision Date
- March 25, 1991
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
FDA 510(k)
FDA Class 2
·Cardiovascular
Arterial Pressure Monitoring Set/Tray
FDA 510(k)
FDA Class 2
·Cardiovascular
DualView Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
pNOVUS 21 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Impress Angiographic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Applied Vascular Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911730 | SURGICAL OBTURATOR WITH SEAL | Dec 23, 1991 | Substantially Equivalent |
| K911589 | DISPOSABLE SURGICAL TROCAR WITH SEAL | Jul 5, 1991 | Substantially Equivalent |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | May 29, 1991 | Substantially Equivalent |
| K910372 | INTIMAX THROMBECTOMY CATHETER | Apr 26, 1991 | Substantially Equivalent |
| K911181 | INTIMAX(TM) IRRIGATION CATHETER | Apr 18, 1991 | Substantially Equivalent |
| K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | Mar 28, 1991 | Substantially Equivalent |
| K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | Mar 21, 1991 | Substantially Equivalent |
| K910079 | DISPOSABLE INTRODUCER SHEATH | Feb 27, 1991 | Substantially Equivalent |
| K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | Feb 15, 1991 | Substantially Equivalent |
| K904379 | SURGICAL TROCAR AND CANNULA | Dec 21, 1990 | Substantially Equivalent |