NASAL OXYGEN CANNULA, #017207
FDA 510(k) clearance K771074 · decided 1977-08-04
Clearance details
- K-number
- K771074
- Device name
- NASAL OXYGEN CANNULA, #017207
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-14
- Decision date
- 1977-08-04
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- CAT
- Device class
- 1
- Regulation number
- 868.5340
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI (K011125) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| NASAL CANNULA (K935533) | Puritas Health Care, Inc. | 1994-02-03 |
| 4 SURE TM NASAL OXYGEN CANNULA (K922397) | Boston Pacific Medical, Inc. | 1993-03-18 |
| SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (K921496) | Alpine Specialties, Inc. | 1992-08-14 |
| CANNULA NASAL OXYGEN (K920573) | B & F Medical Products, Inc. | 1992-08-11 |
| NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (K913421) | Specialty Packaging Producs, Inc. | 1991-10-18 |
| SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (K912197) | Alpine Specialties, Inc. | 1991-08-20 |
| SALTER LABS NEONATAL NASAL OXYGEN CANNULA (K911740) | Salter Labs | 1991-07-24 |
| CATHETER, NASAL, OXYGEN (K902420) | Gainor Medical Europe, Ltd. | 1991-04-17 |
| THE COMFORTABLE CANNULA (K896036) | Comfortable Concepts Corp. | 1989-11-17 |
| KENDALL CURITY OXYGEN NASAL CANNULA (K892435) | The Kendal Co. | 1989-06-12 |
| COMFORT STRAP (K884149) | Comfort Strap Co. | 1988-10-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |