Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

K-Number: K990483 · 1999-06-03

ApplicantBiotronik, Inc.
Decision Date1999-06-03
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K990483. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777?

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Biotronik, Inc.. The 510(k) number is K990483.

When did RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 receive FDA 510(k) clearance?

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 received FDA 510(k) clearance on 1999-06-03, under 510(k) number K990483.

Who is the listed applicant for RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777?

The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777?

The FDA product code for RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 is DTB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biotronik, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261074BIOMONITOR IV (471155)K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterK242969Pantera Pro; Pantera LEOK240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)K241711Oscar Peripheral Multifunctional Catheter systemK230375BIOMONITOR IV

View all 79 devices →

Related Devices (Code: DTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑