Heartport, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Heartport, Inc.” (first 1996, latest 2000), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 141 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 11 | 11 |
| DXC | Clamp, Vascular | 5 | 5 |
| DRC | Trocar | 2 | 2 |
| DSS | Clip, Vascular | 1 | 1 |
| DWZ | Device, Biopsy, Endomyocardial | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 1 | 1 |
Review panels
Most recent Heartport, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP | DWF | 2000-05-05 | 141 |
| K981995 | QUICKDRAW VENOUS CANNULA | DWF | 1999-04-20 | 316 |
| K990772 | DIRECTFLOW ARTERIAL CANNULA | DWF | 1999-03-23 | 14 |
| K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER | DWF | 1998-09-04 | 170 |
| K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER | DWF | 1998-07-15 | 208 |
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER | DWZ | 1997-12-16 | 40 |
| K972570 | HEARTPORT INTRODUCER SHEATH | DYB | 1997-10-01 | 83 |
| K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA | DWF | 1997-06-17 | 71 |
| K970496 | HEARTPORT MAZE SYSTEM: CRYOPROBE SET | OCL | 1997-05-09 | 88 |
| K964302 | HEARTPORT THORACIC TROCAR | DRC | 1997-05-09 | 192 |
14 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-04-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Heartport, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Heartport, Inc.” (first 1996, latest 2000), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heartport, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heartport, Inc. is 141 days.
Which FDA product codes appear under Heartport, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 11); DXC (Clamp, Vascular, 5); DRC (Trocar, 2).
Next steps
- See all 24 Heartport, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Heartport, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.