ARTAP ARTERIAL BLOOD SAMPLING DEVICE
FDA 510(k) clearance K843360 · decided 1984-10-31
Clearance details
- K-number
- K843360
- Device name
- ARTAP ARTERIAL BLOOD SAMPLING DEVICE
- Applicant
- Analytical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-28
- Decision date
- 1984-10-31
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- CBT
- Device class
- 1
- Regulation number
- 868.1100
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Belmont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (K071269) | Smiths Medical Asd, Inc. | 2007-08-01 |
| SECURE ARTERIAL BLOOD SAMPLING SYSTEM (K070340) | Smiths Medical Asd, Inc. | 2007-03-15 |
| ABC IN-LINE BLOOD SAMPLING KIT (K955663) | Utah Medical Products, Inc. | 1997-03-17 |
| ABG POINT LOK NEEDLE PROTECTION DEVICE (K954015) | Devon Industries, Inc. | 1995-11-20 |
| ACTI-FLEX ARTERIAL EXTENSION SET (K954035) | R-Group Intl. | 1995-09-25 |
| NEEDLE SAFETY COVER (K950098) | Hammer-Plane, Inc. | 1995-08-11 |
| ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (K945719) | Sherwood Medical Co. | 1995-03-16 |
| PISTON SYRINGE (K944941) | Martell Medical Products, Inc. | 1994-12-05 |
| ABG NEEDLE PROTECTION (K945485) | Devon Industries, Inc. | 1994-11-29 |
| ASPIR-PULSE(TM) SAF-T-VENT (K940575) | Sherwood Medical Co. | 1994-03-22 |
| VACVENT (K931873) | Steven Frank Mercereau | 1993-12-30 |
| BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 (K930986) | Customed, Inc. | 1993-07-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S010) | Analytical Products, Inc. | 1984-05-04 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S009) | Analytical Products, Inc. | 1984-04-24 |
| UNISCEPT(TM) (P830028/S001) | Analytical Products, Inc. | 1984-03-09 |
| UNISCEPT(TM) (P830028) | Analytical Products, Inc. | 1984-03-01 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S007) | Analytical Products, Inc. | 1983-11-25 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S008) | Analytical Products, Inc. | 1983-11-17 |
| OMNISCEPT(TM) KB SYSTEM (P800029/S005) | Analytical Products, Inc. | 1983-07-05 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S003) | Analytical Products, Inc. | 1982-06-18 |