PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
FDA 510(k) clearance K962856 · decided 1996-08-28
Clearance details
- K-number
- K962856
- Device name
- PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
- Applicant
- Deknatel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-22
- Decision date
- 1996-08-28
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KDQ
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fall River, 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 |
|---|---|---|
| EXPRESS CHEST DRAIN (K081718) | Atrium Medical Corp. | 2008-07-25 |
| MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (K062302) | Millicore AB | 2006-10-06 |
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |
| ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (K984496) | Atrium Medical Corp. | 1999-05-05 |
| 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 |
| ATRIUM 2000, CHEST DRAIN (K897125) | Atrium Medical Corp. | 1990-03-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Onl recall (Z-1404-2015) | Teleflex Medical | 2015-04-08 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006) | Deknatel, Inc. | 1989-06-16 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S011) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S010) | Deknatel, Inc. | 1989-02-02 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005) | Deknatel, Inc. | 1989-01-31 |
| DEKLENE(TM) (P810028/S008) | Deknatel, Inc. | 1989-01-31 |
| CHROMIC GUT SUTURE (N84381/S007) | Deknatel, Inc. | 1989-01-31 |
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004) | Deknatel, Inc. | 1989-01-31 |