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FDA 510(k)

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM

K-Number: K961287 · 1996-07-26

ApplicantRocket Medical Plc
Decision Date1996-07-26
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 1996-07-26 under 510(k) number K961287. The device is classified under product code KDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-26. The listed applicant is Rocket Medical Plc. The 510(k) number is K961287.

When did ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM receive FDA 510(k) clearance?

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM received FDA 510(k) clearance on 1996-07-26, under 510(k) number K961287.

Who is the listed applicant for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

The FDA 510(k) record lists Rocket Medical Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

The FDA product code for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM is KDQ.

Related Clinical Trials

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Other records listing Rocket Medical Plc 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.

K210509Rocket Platinum Cured CathterK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetK123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BK052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

View all 19 devices →

Related Devices (Code: KDQ)

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.

K081718EXPRESS CHEST DRAINAtrium Medical Corp.K062302MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEMMillicore ABK043582OCEAN CHEST DRAINAtrium Medical Corp.K984496ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAINAtrium Medical Corp.K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRDeknatel, Inc.K962168MUCUS SPECIMEN TRAPSage Products, 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.

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