FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GESCO PER-Q-CATH CATHETER INTRODUCER
K Number: K915167
·
Decision Jan 27, 1992
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
26
Review Days
73
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Basic Information
- Device Name
- GESCO PER-Q-CATH CATHETER INTRODUCER
- K Number
- K915167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gesco Intl., Inc.
- Date Received
- November 15, 1991
- Decision Date
- January 27, 1992
- 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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Other Clearances by Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940870 | UMBILI-CATH | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K931989 | VENTRI-CATH | Jul 21, 1993 | Substantially Equivalent |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |