FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K Number: K891021
·
Decision Sep 18, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
16
Review Days
202
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Basic Information
- Device Name
- TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
- K Number
- K891021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Ideal Medical, Inc.
- Date Received
- February 28, 1989
- Decision Date
- September 18, 1989
- Product Code
- DXE
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
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Other Clearances by Ideal Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944067 | PEANUT WAND, MODIFICATION | Dec 8, 1994 | Substantially Equivalent |
| K931115 | HATCHER STONE-EMBOLIS EXTRACTOR | Aug 20, 1993 | Substantially Equivalent |
| K926335 | IDEAS PEANUT WAND | Jun 24, 1993 | Substantially Equivalent |
| K922161 | GRICE SOFT TISSUE BIOPSY KIT | Oct 13, 1992 | Substantially Equivalent |
| K921922 | GRICE LAPAROSCOPIC SUTURING NEEDLE | Jul 8, 1992 | Substantially Equivalent |
| K915175 | REDDICK RETRACTOR | Apr 29, 1992 | Substantially Equivalent |
| K914880 | DUAL BALLOON EMBOLECTOMY CATHETER | Mar 16, 1992 | Substantially Equivalent |
| K913602 | IDEAS' PORT | Jan 2, 1992 | Unknown |
| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | Dec 31, 1991 | Substantially Equivalent |
| K912540 | CONTOUR-PORT | Aug 23, 1991 | Unknown |