PLEUROFIX THORACENTESIS KIT
FDA 510(k) clearance K820004 · decided 1982-02-04
Clearance details
- K-number
- K820004
- Device name
- PLEUROFIX THORACENTESIS KIT
- Applicant
- Burron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-04
- Decision date
- 1982-02-04
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GAZ
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| SUCTION/IRRIGATOR TUBING KIT (K952605) | Surgical Laser Technologies, Inc. | 1995-09-15 |
| TUBING, NONINVASIVE (K945978) | Endoscopic Technologies, Inc. | 1995-01-11 |
| SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (K930512) | Core Dynamics, Inc. | 1993-07-23 |
| NORTEC CONNECTING TUBE SET (K911865) | North American Sterilization & Packaging Co. | 1991-11-01 |
| MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (K910471) | Baxter Healthcare Corp | 1991-03-08 |
| MAXI-FLOW SUCTION SET W/Y CONNECTOR (K910171) | Adler Instrument Co. | 1991-02-01 |
| MAXI-FLOW SUCTION SET 12 FT. (K910170) | Adler Instrument Co. | 1991-02-01 |
| VIR-A-VAC EMPTY (K882315) | Viratec Corp. | 1988-09-26 |
| SURGICAL CONNECTING TUBES (K883473) | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-08-25 |
| 5 - IN - 1 CONNECTOR (K864964) | Medovations, Inc. | 1987-01-20 |
| 5 IN 1 CONNECTOR (K861757) | Jackson Plastics, Inc. | 1986-06-06 |
| PHARMA-PLAST SMOOTH BORE CONNECTORS (K843476) | Zimmar Consulting , Ltd. | 1984-09-24 |
Recalls involving this device
No recalls on record reference this clearance.