FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER
K Number: K864537
·
Decision Jun 19, 1987
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
19
Review Days
214
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Basic Information
- Device Name
- 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER
- K Number
- K864537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Aries Medical, Inc.
- Date Received
- November 17, 1986
- Decision Date
- June 19, 1987
- Product Code
- DSP
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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Other Clearances by Aries Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912604 | SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF | Oct 28, 1991 | Substantially Equivalent |
| K903925 | ARIES MELDICAL MODEL 2100HC HANK CRANK | Dec 21, 1990 | Substantially Equivalent |
| K903442 | ARIES TAPERSEAL(TM) SHEATH | Aug 23, 1990 | Substantially Equivalent |
| K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS | Apr 10, 1990 | Substantially Equivalent |
| K882289 | ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. | Dec 12, 1988 | Substantially Equivalent |
| K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER | Jun 19, 1987 | Substantially Equivalent |
| K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER | May 12, 1987 | Substantially Equivalent |
| K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER | May 12, 1987 | Substantially Equivalent |
| K871140 | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER | Apr 22, 1987 | Substantially Equivalent |
| K870189 | ARIES TAPERED SHEATH | Mar 16, 1987 | Substantially Equivalent |