FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLEUROFIX THORACENTESIS KIT
K Number: K820004
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
26
Applicant Total
41
Review Days
31
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Basic Information
- Device Name
- PLEUROFIX THORACENTESIS KIT
- K Number
- K820004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical Products, Inc.
- Date Received
- January 4, 1982
- Decision Date
- February 4, 1982
- Product Code
- GAZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAZ | Tubing, Noninvasive | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAZ), ordered by most recent decision date.
SUCTION/IRRIGATOR TUBING KIT
FDA 510(k)
FDA Class 2
·General Hospital
TUBING, NONINVASIVE
FDA 510(k)
FDA Class 2
·General Hospital
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
FDA 510(k)
FDA Class 2
·General Hospital
NORTEC CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION SET W/Y CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Burron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | May 1, 1987 | Substantially Equivalent |
| K862412 | INTESTOPLANT | Nov 13, 1986 | Substantially Equivalent |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Jul 1, 1986 | Unknown |
| K860126 | STIMUPLEX, NERVE STIMULATOR | Feb 28, 1986 | Substantially Equivalent |
| K851293 | IMPLANTOFIX | Jan 9, 1986 | Substantially Equivalent |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | Jul 9, 1984 | Substantially Equivalent |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | May 1, 1984 | Substantially Equivalent |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | May 1, 1984 | Substantially Equivalent |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Apr 30, 1984 | Substantially Equivalent |
| K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | Feb 24, 1984 | Substantially Equivalent |