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FDA 510(k)

CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT

K-Number: K972867 · 1997-10-24

ApplicantRocket Medical Plc
Decision Date1997-10-24
Product CodeICX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT 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 1997-10-24 under 510(k) number K972867. The device is classified under product code ICX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT?

CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Rocket Medical Plc. The 510(k) number is K972867.

When did CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT receive FDA 510(k) clearance?

CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT received FDA 510(k) clearance on 1997-10-24, under 510(k) number K972867.

Who is the listed applicant for CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT?

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 CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT?

The FDA product code for CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT is ICX.

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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

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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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