FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD
K Number: K843261
·
Decision Sep 11, 1984
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
14
Review Days
22
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
- ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD
- K Number
- K843261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Angiosystems, Inc.
- Date Received
- August 20, 1984
- Decision Date
- September 11, 1984
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRE), ordered by most recent decision date.
ProtekDilate Vascular Access Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Gold Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Angiosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905464 | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | May 31, 1991 | Unknown |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | Apr 5, 1991 | Substantially Equivalent |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Mar 5, 1991 | Unknown |
| K905466 | STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE | Feb 11, 1991 | Substantially Equivalent |
| K905465 | STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE | Feb 11, 1991 | Substantially Equivalent |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Feb 6, 1991 | Substantially Equivalent |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | Feb 6, 1991 | Substantially Equivalent |
| K905463 | GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION | Jan 22, 1991 | Unknown |
| K864688 | ARNOLD-KING PRESSURE DRESSING | Jan 12, 1987 | Substantially Equivalent |
| K843258 | ANGIO SYS BRACHIAL ANGIO DRAPE | Sep 21, 1984 | Substantially Equivalent |