FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
K Number: K913267
·
Decision Jun 5, 1992
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
7
Review Days
318
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Basic Information
- Device Name
- R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
- K Number
- K913267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R-Group Intl.
- Date Received
- July 23, 1991
- Decision Date
- June 5, 1992
- Product Code
- DRC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
| K001233 | ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S | Dec 13, 2000 | Substantially Equivalent |
| K001599 | ACTI-FLEX IV ADMINISTRATION SET | Sep 18, 2000 | Substantially Equivalent |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | May 25, 2000 | Substantially Equivalent |
| K952470 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | Nov 28, 1995 | Substantially Equivalent |
| K954035 | ACTI-FLEX ARTERIAL EXTENSION SET | Sep 25, 1995 | Substantially Equivalent |
| K940319 | R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE | Nov 10, 1994 | Substantially Equivalent |