HYDROPHILIC COATED CATHETER
FDA 510(k) clearance K810023 · decided 1981-02-06
Clearance details
- K-number
- K810023
- Device name
- HYDROPHILIC COATED CATHETER
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1981-01-05
- Decision date
- 1981-02-06
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- BSY
- Device class
- 1
- Regulation number
- 868.6810
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, 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 |
|---|---|---|
| MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (K031997) | Mallinckrodt Dar S.R.L. | 2003-11-25 |
| AMBU HAND POWER SUCTION PUMP (K992902) | Ambu, Inc. | 1999-10-25 |
| DUAL PURPOSE CLOSED CATHETER (K982945) | Spirit Medical Systems, Inc. | 1998-09-22 |
| SUCTION CATHETER (K981910) | Ni-Med, Inc. | 1998-08-24 |
| HI-CARE CLOSED SUCTION SYSTEM (K972258) | Mallinckrodt Medical | 1997-12-29 |
| AMSINO SUCTION CATHETER (K973199) | Amsino Intl., Inc. | 1997-09-10 |
| TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (K961707) | Sorenson Critical Care | 1997-03-11 |
| TRACH CARE SET WITH MICROBAN (K964369) | Ballard Medical Products | 1997-02-11 |
| NEO 2 LINE SUCTION SYSTEM (K960488) | Alcove Medical, Inc. | 1996-04-26 |
| ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (K955831) | Sherwood Medical Co. | 1996-03-28 |
| CATH-GUIDE (K955645) | Hudson Respiratory Care, Inc. | 1996-03-12 |
| REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (K952396) | Contour Fabricators of Florida, Inc. | 1995-08-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |