FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GSI CANNULA WITH INTRODUCER
K Number: K970201
·
Decision Apr 21, 1997
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- GSI CANNULA WITH INTRODUCER
- K Number
- K970201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Surgical Innovations
- Date Received
- January 21, 1997
- Decision Date
- April 21, 1997
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | Nov 14, 1997 | Substantially Equivalent |
| K962702 | SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA | Feb 19, 1997 | Substantially Equivalent |
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| K952278 | THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA | Aug 7, 1995 | Substantially Equivalent |
| K951878 | SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA | Jun 29, 1995 | Substantially Equivalent |
| K944418 | THE SPACEMAKER AND THE SPACEMAKER II | Nov 1, 1994 | Substantially Equivalent |
| K944536 | GSI KNOTMAKER | Oct 5, 1994 | Substantially Equivalent |
| K943671 | GSI CANNULA REDUCER ACCESSORY | Aug 9, 1994 | Substantially Equivalent |