FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAVENOUS CATHETERS MODIFICATIONS
K Number: K921295
·
Decision May 17, 1993
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
18
Applicant Total
51
Review Days
431
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Basic Information
- Device Name
- INTRAVENOUS CATHETERS MODIFICATIONS
- K Number
- K921295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Critikon Company, LLC
- Date Received
- March 12, 1992
- Decision Date
- May 17, 1993
- Product Code
- FGO
- 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 |
|---|---|---|---|
| FGO | Dislodger, Stone, Flexible | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGO), ordered by most recent decision date.
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
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STONE DISLODGER, BASKET
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RETRIEVAL SNARE
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DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STONE DISLODGER, BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRASPING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Critikon Company, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K002248 | DINAMAP PRO 1000 MONITOR, MODEL 1000 | Sep 21, 2000 | Substantially Equivalent |
| K000500 | DINAMAP ADVANCED NIBP MODULE | May 26, 2000 | Substantially Equivalent |
| K992638 | DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 | Feb 24, 2000 | Substantially Equivalent |
| K982342 | DINAMAP MPS SELECT PORTABLE MONITOR | Aug 14, 1998 | Substantially Equivalent |
| K943709 | DINAMAP PLUS VITAL SIGNS MONOITOR | Jun 16, 1995 | Substantially Equivalent |
| K942700 | DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 | Mar 1, 1995 | Substantially Equivalent |
| K933404 | CRITIKON CENTRAL STATIN MONITOR | Feb 9, 1994 | Substantially Equivalent |
| K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH | Dec 14, 1993 | Substantially Equivalent |
| K915697 | CRITIKON VITAL SIGNS MODULE | Jul 1, 1993 | Substantially Equivalent |
| K912188 | DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 | Dec 4, 1991 | Substantially Equivalent |