FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
K Number: K974236
·
Decision Apr 15, 1999
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
37
Applicant Total
63
Review Days
519
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Basic Information
- Device Name
- MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
- K Number
- K974236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Components, Inc.
- Date Received
- November 12, 1997
- Decision Date
- April 15, 1999
- Product Code
- MPB
- 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 |
|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medical Components, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | Jan 8, 2014 | Substantially Equivalent |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | Aug 16, 2013 | Substantially Equivalent |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | Aug 15, 2013 | Substantially Equivalent |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Jul 31, 2013 | Substantially Equivalent |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | Jun 3, 2013 | Substantially Equivalent |
| K123617 | 3F PRO-PICC | May 15, 2013 | Substantially Equivalent |
| K122423 | VASU-PICC | Dec 12, 2012 | Substantially Equivalent |
| 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 |