FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ANGIO SYS FLUOROSCOPE DRAPE
K Number: K843259
·
Decision Sep 21, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
32
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Basic Information
- Device Name
- ANGIO SYS FLUOROSCOPE DRAPE
- K Number
- K843259
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Angiosystems, Inc.
- Date Received
- August 20, 1984
- Decision Date
- September 21, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |