GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
FDA 510(k) clearance K851244 · decided 1985-11-19
Clearance details
- K-number
- K851244
- Device name
- GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-26
- Decision date
- 1985-11-19
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- KDQ
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- New Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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| ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (K961287) | Rocket Medical Plc | 1996-07-26 |
| MUCUS SPECIMEN TRAP (K962168) | Sage Products, Inc. | 1996-07-22 |
| ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (K950677) | Atrium Medical Corp. | 1995-04-13 |
| PM9000 VAC TRAP (K941818) | Precision Medical, Inc. | 1994-12-12 |
| THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (K932327) | Davol, Inc. | 1993-07-13 |
| ATRIUM 2000 CHEST DRAIN (K912704) | Atrium Medical Corp. | 1991-08-26 |
| PLEUR-EVAC CHEST DRAINAGE SYSTEMS (K905768) | Deknatel, Inc. | 1991-02-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |