FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEARTPORT NEEDLE TROCAR
K Number: K965051
·
Decision Mar 12, 1997
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
24
Review Days
84
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Basic Information
- Device Name
- HEARTPORT NEEDLE TROCAR
- K Number
- K965051
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heartport, Inc.
- Date Received
- December 18, 1996
- Decision Date
- March 12, 1997
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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Other Clearances by Heartport, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP | May 5, 2000 | Substantially Equivalent |
| K981995 | QUICKDRAW VENOUS CANNULA | Apr 20, 1999 | Substantially Equivalent |
| K990772 | DIRECTFLOW ARTERIAL CANNULA | Mar 23, 1999 | Substantially Equivalent |
| K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER | Sep 4, 1998 | Substantially Equivalent |
| K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER | Jul 15, 1998 | Substantially Equivalent |
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER | Dec 16, 1997 | Substantially Equivalent |
| K972570 | HEARTPORT INTRODUCER SHEATH | Oct 1, 1997 | Substantially Equivalent |
| K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA | Jun 17, 1997 | Substantially Equivalent |
| K970496 | HEARTPORT MAZE SYSTEM: CRYOPROBE SET | May 9, 1997 | Substantially Equivalent |
| K964302 | HEARTPORT THORACIC TROCAR | May 9, 1997 | Substantially Equivalent |