Hotspur Technologies: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Hotspur Technologies” (first 2010, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 109 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 | 1 | 29 |
| 2013 | 1 | 121 |
| 2014 | 1 | 30 |
| 2015 | 1 | 239 |
| 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 5 | 5 |
| DXE | Catheter, Embolectomy | 2 | 2 |
Review panels
- Cardiovascular (7)
Most recent Hotspur Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) | LIT | 2015-06-24 | 239 |
| K142300 | Arrow GPSCath Balloon Dialation Catheter (150 cm) | LIT | 2014-09-17 | 30 |
| K130397 | ARROW GPSCATH BALLOON DILATATION CATHETER | LIT | 2013-06-20 | 121 |
| K113769 | GPSCATH BALLON DILATATION CATHETER | LIT | 2012-01-20 | 29 |
| K101047 | PTA-DUO PTA BALLOON CATHETER | LIT | 2010-07-13 | 90 |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | DXE | 2010-07-12 | 109 |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | DXE | 2010-07-12 | 110 |
Recalls
openFDA lists no recalls under a recalling firm named Hotspur Technologies.
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.
- Hotspur Technologies,Inc Subsidiary of Teleflex ME (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hotspur Technologies?
FDA lists 7 510(k) clearances under the applicant name “Hotspur Technologies” (first 2010, latest 2015), 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 Hotspur Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hotspur Technologies is 109 days.
Which FDA product codes appear under Hotspur Technologies?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 5); DXE (Catheter, Embolectomy, 2).
Next steps
- See all 7 Hotspur Technologies clearances with predicates and recalls
- Run predicate analysis for product code LIT, Hotspur Technologies'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.