FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K Number: K893439
·
Decision Jun 13, 1989
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
63
Review Days
41
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Basic Information
- Device Name
- HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
- K Number
- K893439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Components, Inc.
- Date Received
- May 3, 1989
- Decision Date
- June 13, 1989
- Product Code
- LFJ
- 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 |
|---|---|---|---|
| LFJ | Catheter, Subclavian | FDA class 2 | Gastroenterology, Urology |
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| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | Sep 21, 2012 | Unknown |