FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BALT INTRODUCER
K Number: K925633
·
Decision Jun 25, 1993
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
70
Review Days
228
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Basic Information
- Device Name
- BALT INTRODUCER
- K Number
- K925633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Target Therapeutics
- Date Received
- November 9, 1992
- Decision Date
- June 25, 1993
- 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 Target Therapeutics
| K Number | Device Name | ||
|---|---|---|---|
| K965071 | DETACHABLE SLICONE BALLOON (DSB) | Apr 21, 1998 | Substantially Equivalent |
| K964488 | DETACHABLE SILICONE BALLOON (DSB) | Apr 21, 1998 | Substantially Equivalent |
| K964210 | RETRIEVER II | Oct 31, 1997 | Substantially Equivalent |
| K971395 | GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE | Jul 14, 1997 | Substantially Equivalent |
| K965189 | SPINNAKER | Mar 24, 1997 | Substantially Equivalent |
| K964112 | BERENSTEIN COIL | Feb 26, 1997 | Substantially Equivalent |
| K963307 | GDC PATIENT RETURN ELECTTRODE MODEL 45021 | Dec 17, 1996 | Substantially Equivalent |
| K962503 | GUGLIELMI DETACHABLE COIL | Sep 20, 1996 | Substantially Equivalent |
| K961923 | BERENSTEIN COIL | Aug 15, 1996 | Substantially Equivalent |
| K960705 | GUGLIELMI DETACHABLE COIL | May 21, 1996 | Substantially Equivalent |