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FDA 510(k)

TUNNELER

K-Number: K943968 · 1995-03-01

ApplicantDenver Biomedicals, Inc.
Decision Date1995-03-01
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TUNNELER is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomedicals, Inc.. It received FDA 510(k) clearance on 1995-03-01 under 510(k) number K943968. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUNNELER?

TUNNELER is a medical device that received FDA 510(k) clearance on 1995-03-01. The listed applicant is Denver Biomedicals, Inc.. The 510(k) number is K943968.

When did TUNNELER receive FDA 510(k) clearance?

TUNNELER received FDA 510(k) clearance on 1995-03-01, under 510(k) number K943968.

Who is the listed applicant for TUNNELER?

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

What is the FDA product code for TUNNELER?

The FDA product code for TUNNELER is MDM.

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Other records listing Denver Biomedicals, 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.

K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEK011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERK010642PLEURX PLEURAL CATHETER AND DRAINAGE KITSK003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES TK913728DENVER(R) PERITONEO-SUBCLAVIAN SHUNTK842139THE DENVER PLEURAL-PERITONEAL SHUNT

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Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, 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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