FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACKRAD ERCP CONTRAST DELIVERY SET
K Number: K915813
·
Decision Mar 11, 1992
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
42
Review Days
72
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Basic Information
- Device Name
- ACKRAD ERCP CONTRAST DELIVERY SET
- K Number
- K915813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ackrad Laboratories
- Date Received
- December 30, 1991
- Decision Date
- March 11, 1992
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Ackrad Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | May 21, 2002 | Substantially Equivalent |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | Apr 24, 2002 | Substantially Equivalent |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | Apr 16, 2002 | Substantially Equivalent |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | Apr 9, 1997 | Substantially Equivalent |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 8, 1996 | Substantially Equivalent |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Apr 23, 1996 | Substantially Equivalent |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | Apr 23, 1996 | Substantially Equivalent |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 29, 1995 | Substantially Equivalent |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 1, 1991 | Substantially Equivalent |
| K911780 | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED | Jun 24, 1991 | Substantially Equivalent |