BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
FDA 510(k) clearance K884063 · decided 1988-12-16
Clearance details
- K-number
- K884063
- Device name
- BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-26
- Decision date
- 1988-12-16
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- CCE
- Device class
- 2
- Regulation number
- 868.1200
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tewksbury, MA, 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 |
|---|---|---|
| VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (K935778) | Via Medical Corp. | 1996-12-05 |
| SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (K912145) | S & W Medico Teknik | 1992-05-05 |
| TOPS NEEDLE TIP PROBE & PVC TIP PROBE (K910453) | Baxter Healthcare Corp | 1991-08-13 |
| PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (K905397) | Puritan Bennett Corp. | 1991-05-14 |
| OPTEX BLOOD GAS MONITORING SYSTEM (K896311) | Optex Biomedical | 1990-01-03 |
| TISSUE OXYGEN MONITOR SYSTEM, MODEL II (K890624) | Baxter Healthcare Corp | 1989-12-22 |
| NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (K895149) | Shiley, Inc. | 1989-11-28 |
| CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (K895150) | Shiley, Inc. | 1989-11-28 |
| UMBILICAL ARTERY OXYGEN SENSOR (K875225) | Ohmeda Medical | 1988-03-04 |
| UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (K872896) | American Bentley | 1988-02-12 |
| BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM (K872125) | C.R. Bard, Inc. | 1987-12-11 |
| CONTINUCATH (K860808) | Orange Medical Instruments, Inc. | 1986-03-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035) | C.R. Bard, Inc. | 2026-07-15 |
| Covera Vascular Covered Stent (P170042/S015) | C.R. Bard, Inc. | 2026-06-10 |
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |