FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
K Number: K980917
·
Decision May 27, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
6
Review Days
77
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Basic Information
- Device Name
- ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
- K Number
- K980917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fortune Medical Instrument Corp.
- Date Received
- March 11, 1998
- Decision Date
- May 27, 1998
- Product Code
- GCA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Fortune Medical Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K022112 | FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 | Apr 3, 2003 | Substantially Equivalent |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Feb 12, 2003 | Substantially Equivalent |
| K021142 | ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 | Oct 1, 2002 | Substantially Equivalent |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | Mar 4, 2002 | Substantially Equivalent |
| K980919 | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER | Mar 31, 1998 | Substantially Equivalent |