Heartport Thoracic Surgical Trocars: (TOST-4-3, TOSTL-6-3, TON-4-2 and TONL-6-2
FDA 510(k) K961463 · Heartport, Inc.
510(k) numberK961463
Submission
- Device name
- Heartport Thoracic Surgical Trocars: (TOST-4-3, TOSTL-6-3, TON-4-2 and TONL-6-2
- Applicant
- Heartport, Inc.
Redwood City, CA, US - Received
- April 17, 1996
- Decision date
- October 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K981009 | Heartport Endopulmonary Vent CatheterDWF · Traditional | 09/04/1998SE |
| K974736 | Heartport Direct Aortic Return Cannula with IntroducerDWF · Traditional | 07/15/1998SE |
| K974175 | Heartport Endoaortic Clamp CatheterDWZ · Traditional | 12/16/1997SE |
| K972570 | Heartport Introducer SheathDYB · Traditional | 10/01/1997SE |
| K971291 | Heartport Endoarterial Return CannulaDWF · Traditional | 06/17/1997SE |
| K970496 | Heartport Maze System: Cryoprobe SetOCL · Traditional | 05/09/1997SE |
| K964302 | Heartport Thoracic TrocarDRC · Traditional | 05/09/1997SE |
Questions and answers
When was Heartport Thoracic Surgical Trocars: (TOST-4-3, TOSTL-6-3, TON-4-2 and TONL-6-2 cleared by the FDA?
Heartport Thoracic Surgical Trocars: (TOST-4-3, TOSTL-6-3, TON-4-2 and TONL-6-2 (K961463) received a 510(k) decision of Substantially Equivalent on October 8, 1996, 174 days after the submission was received.
What is the product code of K961463?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.