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FDA 510(k)

CATAPULT BUCKY (KATAPULT BLENDA)

K-Number: K883160 · 1988-09-08

ApplicantBay X-Ray, Inc.
Decision Date1988-09-08
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CATAPULT BUCKY (KATAPULT BLENDA) is the device name listed in this FDA 510(k) record. The listed applicant is Bay X-Ray, Inc.. It received FDA 510(k) clearance on 1988-09-08 under 510(k) number K883160. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATAPULT BUCKY (KATAPULT BLENDA)?

CATAPULT BUCKY (KATAPULT BLENDA) is a medical device that received FDA 510(k) clearance on 1988-09-08. The listed applicant is Bay X-Ray, Inc.. The 510(k) number is K883160.

When did CATAPULT BUCKY (KATAPULT BLENDA) receive FDA 510(k) clearance?

CATAPULT BUCKY (KATAPULT BLENDA) received FDA 510(k) clearance on 1988-09-08, under 510(k) number K883160.

Who is the listed applicant for CATAPULT BUCKY (KATAPULT BLENDA)?

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

What is the FDA product code for CATAPULT BUCKY (KATAPULT BLENDA)?

The FDA product code for CATAPULT BUCKY (KATAPULT BLENDA) is KPR.

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 Bay X-Ray, 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.

K883161HIMOBILIX 2NK883155RASTIX X-RAY TABLEK883153UNDISTAT WITH EXPLORATOR 35 (UCS 35E)K883162TELESTATIX X-RAY TABLEK883154SELDIX 325 TWO PULSE GENERATOR/CONTROL

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Official Source

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

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