FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE THORACIC CATHETER
K Number: K813587
·
Decision Jan 12, 1982
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
30
Review Days
15
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Basic Information
- Device Name
- DISPOSABLE THORACIC CATHETER
- K Number
- K813587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Texas Medical Products, Inc.
- Date Received
- December 28, 1981
- Decision Date
- January 12, 1982
- Product Code
- GBS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBS), ordered by most recent decision date.
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URESIL WOUND DRAIN TROCAR
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NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
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CLOSED CHEST DRAINAGE SET W/SUTURES
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Other Clearances by Texas Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | Jun 22, 1989 | Substantially Equivalent |
| K870932 | SURGIFRESH SURGICAL SMOKE REMOVAL | Mar 31, 1987 | Substantially Equivalent |
| K851575 | DR. BRUNO LNAGE MINI PHOTOMETER | Oct 18, 1985 | Substantially Equivalent |
| K830634 | CARDIOTOMY FILTER | Jun 30, 1983 | Substantially Equivalent |
| K810532 | DISPOSABLE STOPCOCK | Apr 23, 1981 | Substantially Equivalent |
| K810515 | DISPOSABLE 2-STAGE CANNULA | Apr 23, 1981 | Substantially Equivalent |
| K810395 | PRE-BYPASS FILTER | Mar 5, 1981 | Substantially Equivalent |
| K802545 | CARDIOPLEGIC SETS | Jan 16, 1981 | Substantially Equivalent |
| K802543 | RIDGID VENA CAVA CANNULAE | Jan 16, 1981 | Substantially Equivalent |
| K802544 | DISPOSABLE QUICK RELEASE PERFUSION ADAP | Jan 16, 1981 | Substantially Equivalent |