FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
K Number: K905464
·
Decision May 31, 1991
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
14
Review Days
177
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
- MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
- K Number
- K905464
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Applicant
- Angiosystems, Inc.
- Date Received
- December 5, 1990
- Decision Date
- May 31, 1991
- Product Code
- CBT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBT), ordered by most recent decision date.
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
ABC IN-LINE BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
ABG POINT LOK NEEDLE PROTECTION DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
ACTI-FLEX ARTERIAL EXTENSION SET
FDA 510(k)
FDA Class 1
·Anesthesiology
NEEDLE SAFETY COVER
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Angiosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K843259 | ANGIO SYS FLUOROSCOPE DRAPE | Sep 21, 1984 | Substantially Equivalent |