PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
FDA 510(k) clearance K890129 · decided 1989-04-10
Clearance details
- K-number
- K890129
- Device name
- PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
- Applicant
- Deknatel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-12
- Decision date
- 1989-04-10
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GCX
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Jose-Heredia, CR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Deknatel
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRYKER CASSETTE PUMP (K042454) | Stryker Endoscopy | 2004-12-09 |
| CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126) | Circon Corp. | 1999-08-03 |
| SUCTION INSTRUMENTATION (K972074) | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| CHASE SUCKER (K971022) | Chase Medical, Inc. | 1997-04-17 |
| MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127) | Allegiance Healthcare Corp. | 1996-12-31 |
| CURITY THORACENTESIS TRAY (K964519) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| STRYKER SUCTION REGULATOR (K963648) | Stryker Endoscopy | 1996-11-26 |
| RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (K962920) | R&S Surgical, LLC | 1996-10-21 |
| MEDCARE SUCTION CONNECTING TUBING (K961880) | Medcare Medical Group, Inc. | 1996-07-19 |
| CPR YANKAUER (K960223) | Custom Pack Reliability | 1996-03-28 |
| MEDCARE YANKAUER SUCTION DEVICE (K954869) | Medcare Custom Packaging, Inc. | 1996-01-19 |
| STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726) | Stryker Endoscopy | 1995-11-29 |
Recalls involving this device
No recalls on record reference this clearance.
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 |