Global Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Global Therapeutics, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960014 | PMA | MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520 | 1998-10-05 |
Recalls
openFDA lists no recalls under a recalling firm named Global Therapeutics, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Global Therapeutics, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
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.
- Global Protection Corp. (10 510(k)s)
- Global Medical Prods, Inc. (9 510(k)s)
- Global Endoscopy, Inc. (7 510(k)s)
- Global Medical Products, Ltd. (6 510(k)s)
- Global Instrumentation, LLC (5 510(k)s)
- Global Treasure Industries , Ltd. (5 510(k)s)
- Global Fabtech Wheelchair (Shanghai) Co., Ltd. (4 510(k)s)
- Global USA Distribution, LLC (4 510(k)s)
- Global Healthcare, Inc. (3 510(k)s)
- Global Manufacturing Technology (3 510(k)s)
- Global Orthopaedic Technology, USA, Inc. (3 510(k)s)
- Global TV Concepts, Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Global Therapeutics, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Global Therapeutics, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Global Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 1).
Next steps
- See all 0 Global Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOX, Global Therapeutics, 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.