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FDA 510(k)

DYNABITE CARDIOVASCULAR BIOPSY FORCEPS

K-Number: K951447 · 1995-07-27

ApplicantPortlyn Corp.
Decision Date1995-07-27
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNABITE CARDIOVASCULAR BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Portlyn Corp.. It received FDA 510(k) clearance on 1995-07-27 under 510(k) number K951447. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNABITE CARDIOVASCULAR BIOPSY FORCEPS?

DYNABITE CARDIOVASCULAR BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1995-07-27. The listed applicant is Portlyn Corp.. The 510(k) number is K951447.

When did DYNABITE CARDIOVASCULAR BIOPSY FORCEPS receive FDA 510(k) clearance?

DYNABITE CARDIOVASCULAR BIOPSY FORCEPS received FDA 510(k) clearance on 1995-07-27, under 510(k) number K951447.

Who is the listed applicant for DYNABITE CARDIOVASCULAR BIOPSY FORCEPS?

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

What is the FDA product code for DYNABITE CARDIOVASCULAR BIOPSY FORCEPS?

The FDA product code for DYNABITE CARDIOVASCULAR BIOPSY FORCEPS is DWZ.

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Other records listing Portlyn Corp. 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.

K970083DYNABITE HOT GI BIOPSY FORCEPSK952391DYNABITE UROLOGICAL FORCEPSK944245DYNABITE LAPAROSCOPIC FORCEPSK934506DYNABITE HYSTEROSCOPIC FORCEPSK901300BIOPSY FORCEPSK896147BIOPSY FORCEP (NON-ELECTRIC)

View all 8 devices →

Related Devices (Code: DWZ)

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.

K252722Biopsy ForcepsFehling Instruments GmbHK170726Biopsy ForcepsFehling Instruments GmbH & Co. KGK072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific CorpK991486ULTRA-CBXMedcanica, 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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