Enpath Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Enpath Medical, Inc.” (first 2006, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 4 | 4 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Enpath Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081394 | PTFE INTERLOCK PEELABLE INTRODUCERS | DYB | 2008-09-15 | 119 |
| K072248 | VIAPEEL PEELABLE INTRODUCER | DYB | 2007-11-09 | 88 |
| K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT | DYB | 2007-07-05 | 27 |
| K063182 | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX | DYB | 2006-12-21 | 63 |
| K061119 | ENPATH MEDICAL STEERABLE SHEATH | DQY | 2006-05-18 | 27 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2006-07-18.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Enpath Medical Incorporated (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Enpath Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Enpath Medical, Inc.” (first 2006, latest 2008), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Enpath Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Enpath Medical, Inc. is 63 days.
Which FDA product codes appear under Enpath Medical, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 4); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 5 Enpath Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Enpath Medical, 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.